As filed with the Securities and Exchange Commission on March 18, 2025
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ELUTIA INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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47-4790334
(I.R.S. Employer
Identification No.)
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12510 Prosperity Drive, Suite 370
Silver Spring, MD 20904
(240) 247-1170
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive office)
C. Randal Mills, Ph.D.
President and Chief Executive Officer
Elutia Inc.
12510 Prosperity Drive, Suite 370
Silver Spring, MD 20904
(240) 247-1170
(Address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
David Eaton, Esq.
Michael Cochran, Esq.
Kilpatrick Townsend & Stockton LLP
1100 Peachtree St. NE, 2800
Atlanta, GA 30309
(404) 815-6500
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time to time after the effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☒
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective on filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for comply with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act. ☐
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
This registration statement contains two prospectuses:
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a “base” prospectus, which covers the offering, issuance and sale by Elutia Inc. of up to $100,000,000 of Elutia’s Class A and Class B common stock, preferred stock, debt securities, warrants, and/or units consisting of some or all of these securities; and
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a sales agreement prospectus covering the “at the market offering”, issuance and sale by us of up to a maximum aggregate offering price of $50,000,000 of Elutia’s Class A common stock that may be issued and sold under a sales agreement with Cantor Fitzgerald & Co. as sales agent.
The base prospectus immediately follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The sales agreement prospectus immediately follows the base prospectus. The specific terms of the securities to be issued and sold under the sales agreement with the sales agent are specified in the sales agreement prospectus that immediately follows the base prospectus.
The $50,000,000 of Class A common stock that may be offered, issued and sold under the sales agreement prospectus is included in the $100,000,000 of securities that may be offered, issued and sold by us under the base prospectus. Upon termination of the sales agreement with the sales agent, any portion of the $50,000,000 included in the sales agreement prospectus supplement that is not sold pursuant to the sales agreement will be available for sale in other offerings pursuant to the base prospectus and a corresponding prospectus supplement, and if no additional shares are sold under the sales agreement, the full $100,000,000 of securities may be sold in other offerings pursuant to the base prospectus and a corresponding prospectus supplement.
The information in this prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, dated March 18, 2025.
PROSPECTUS
ELUTIA INC.
$100,000,000
Class A Common Stock
Class B Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may offer and sell up to $100,000,000 in the aggregate of the securities identified above from time to time in one or more offerings. This prospectus provides you with a general description of the securities and the general manner in which these securities will be offered.
Each time we offer and sell securities, we will provide a supplement to this prospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The prospectus supplement will also describe the specific manner in which these securities will be offered and may also add, update or change information contained in this prospectus with respect to that offering. You should carefully read this prospectus and the applicable prospectus supplement before you invest in any of our securities.
We may offer and sell the securities described in this prospectus and any prospectus supplement to or through one or more underwriters, dealers and agents, or directly to purchasers, or through a combination of these methods. If any underwriters, dealers or agents are involved in the sale of any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution” for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing the method and terms of the offering of such securities.
INVESTING IN OUR SECURITIES INVOLVES RISKS. SEE THE “RISK FACTORS” ON PAGE 6 OF THIS PROSPECTUS AND ANY SIMILAR SECTION CONTAINED IN THE APPLICABLE PROSPECTUS SUPPLEMENT CONCERNING FACTORS YOU SHOULD CONSIDER BEFORE INVESTING IN OUR SECURITIES.
Our Class A common stock is listed on the Nasdaq Capital Market under the symbol “ELUT.” On March 17, 2025, the last reported sale price of our Class A common stock on the Nasdaq Capital Market was $3.20 per share.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2025.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the U.S. Securities and Exchange Commission, or the SEC, using a “shelf” registration process. By using a shelf registration statement, we may sell securities from time to time and in one or more offerings up to a total dollar amount of $100,000,000 as described in this prospectus. Each time that we offer and sell securities, we will provide a prospectus supplement to this prospectus that contains specific information about the securities being offered and sold and the specific terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplement or free writing prospectus may also add, update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or free writing prospectus, you should rely on the prospectus supplement or free writing prospectus, as applicable. Before purchasing any securities, you should carefully read both this prospectus and the applicable prospectus supplement (and any applicable free writing prospectuses), together with the additional information described under the heading “Where You Can Find More Information; Incorporation by Reference.”
We have not authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus, any applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We will not make an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus and the applicable prospectus supplement to this prospectus is accurate only as of the date on its respective cover, that the information appearing in any applicable free writing prospectus is accurate only as of the date of that free writing prospectus, and that any information incorporated by reference is accurate only as of the date of the document incorporated by reference, unless we indicate otherwise. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus incorporates by reference, and any prospectus supplement or free writing prospectus may contain and incorporate by reference, market data and industry statistics and forecasts that are based on independent industry publications and other publicly available information. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, the market and industry data and forecasts that may be included or incorporated by reference in this prospectus, any prospectus supplement or any applicable free writing prospectus may involve estimates, assumptions and other risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” contained in this prospectus, the applicable prospectus supplement and any applicable free writing prospectus, and under similar headings in other documents that are incorporated by reference into this prospectus. Accordingly, investors should not place undue reliance on this information.
When we refer to “Elutia,” “we,” “our,” “us” and the “Company” in this prospectus, we mean Elutia Inc. (formerly known as Aziyo Biologics, Inc.) and its consolidated subsidiary, unless otherwise specified. When we refer to “you,” we mean the potential holders of the applicable series of securities.
We use our trademarks and our logo, in this prospectus and the documents incorporated by reference.
This prospectus and the documents incorporated by reference also include trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this prospectus appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
Available Information
We file reports, proxy statements and other information with the SEC. The SEC maintains a web site that contains reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.
Our web site address is www.elutia.com. The information on our web site, however, is not, and should not be deemed to be, a part of this prospectus.
This prospectus and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us, as provided below. Forms of the indenture and other documents establishing the terms of the offered securities are or may be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in this prospectus or any prospectus supplement about these documents are summaries and each statement is qualified in all respects by reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant matters. You may inspect a copy of the registration statement through the SEC’s website, as provided above.
Incorporation by Reference
The SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.
This prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below (SEC File No. 001-39577) that have previously been filed with the SEC (other than those documents or the portions of those documents not deemed to be filed):
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The description of our Class A common stock and Class B common stock contained in Exhibit 4.9 to our Annual Report on Form 10-K for the ended December 31, 2024, filed with the SEC on March 11, 2025, and any amendment or report filed with the SEC for the purpose of updating the description.
All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, which we refer to as the “Exchange Act” in this prospectus, prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports and documents.
You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:
Elutia Inc.
12510 Prosperity Drive, Suite 370
Silver Spring, MD 20904
(240) 247-1170
Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus or any accompanying prospectus supplement.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and any future accompanying prospectus supplement may contain forward-looking statements that involve risks and uncertainties. These forward-looking statements are not historical facts but rather are plans and predictions based on current expectations, estimates, and projections about our industry, our beliefs and assumptions. We use words such as “may,” “could,” “should,” “anticipate,” “expect,” “intend,” “project,” “plan,” “believe,” “seek,” “estimate,” “assume” and variations of these words and similar expressions to identify forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors, some of which are beyond our control, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. You should not place undue reliance on these forward-looking statements. Any forward-looking statements are made only of the date of any accompanying prospectus supplement they appear in or, with respect to statements in documents incorporated by reference, the date of any such document. Over time, our actual results, performance or achievements may differ from those expressed or implied by our forward-looking statements, and such difference might be significant and materially adverse to our security holders. Except as required by law, we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. We have described some of the important factors that could cause future events to differ from our current expectations under the captions “Forward-Looking Statements, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K, as the same may be updated in any subsequently filed Quarterly Reports on Form 10-Q, in any future accompanying prospectus supplement and in other documents that we may file with the SEC, all of which you should review carefully. Please consider our forward-looking statements in light of those risks.
THE COMPANY
At Elutia, our mission is to humanize medicine so that patients can thrive without compromise. As a commercial-stage company, we seek to leverage our unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. These complications include infection, device migration, erosion, implant rejection, non-union of implants, fibrosis and scar formation. Our products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation, and preventing complications such as capsular contraction, erosion, migration and implant rejection. These products currently focus on our priority markets — Device Protection and Women’s Health. We also sell legacy products into the Cardiovascular market.
We were incorporated under the laws of the State of Delaware on August 6, 2015 under the name Aziyo Biologics, Inc. On September 6, 2023, we changed our name to Elutia Inc.
Our principal executive offices are located at 12510 Prosperity Drive, Suite 370, Silver Spring, MD 20904, and our telephone number is (240) 247-1170.
RISK FACTORS
Investment in any securities offered pursuant to this prospectus and the applicable prospectus supplement involves risks. You should carefully consider the risk factors incorporated by reference to our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act, and the risk factors and other information contained in the applicable prospectus supplement and any applicable free writing prospectus before making a decision about investing in our securities. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities.
USE OF PROCEEDS
We intend to use the net proceeds from the sale of the securities as set forth in the applicable prospectus supplement.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our capital stock. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. Any future determination related to our dividend policy will be made at the discretion of our board of directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors the board of directors deems relevant. In addition, our ability to pay cash dividends may be restricted by the terms our current loan or future loan or financing agreements, as described in the documents incorporated by reference herein or in any accompanying prospectus supplement.
DESCRIPTION OF CAPITAL STOCK
Authorized Capital Stock
The following description of our restated certificate of incorporation (the “Certificate of Incorporation”), and amended and restated bylaws (the “Bylaws”) are summaries and are qualified in their entirety by reference to the full text of our Certificate of Incorporation and our Bylaws, each of which have been publicly filed with the Securities and Exchange Commission (the “SEC”). We encourage you to read the full text of our Certificate of Incorporation and our Bylaws and the applicable provisions of the Delaware General Corporation Law (the “DGCL”) for additional information.
Our authorized capital stock consists of 200,000,000 shares of Class A common stock, par value $0.001 per share, 20,000,000 shares of Class B common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share, all of which are undesignated.
Class A Common Stock and Class B Common Stock
Holders of our Class A common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An election of directors by our stockholders shall be determined by a plurality of the votes cast. Subject to the supermajority votes for some matters, all other elections and questions presented to the stockholders shall be decided by the affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively (excluding abstentions) at the meeting by the holders entitled to vote thereon. Our Certificate of Incorporation and Bylaws also provide that our board of directors or any individual director may be removed only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistent with, several of the provisions of our Certificate of Incorporation. See below under “Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws — Amendment of Charter Provisions.”
Holders of our Class B common stock have identical rights to holders of our Class A common stock as set forth in the preceding paragraph, other than as follows: (i) except as otherwise expressly provided in our Certificate of Incorporation or as required by applicable law, on any matter that is submitted to a vote by our stockholders, while holders of our Class A common stock are entitled to one vote per share of Class A common stock, holders of our Class B common stock are not entitled to any votes per share of Class B common stock, including for the election of directors, and (ii) while holders of our Class A common stock have no conversion rights, holders of our Class B common stock shall have the right to convert each share of our Class B common stock into one share of Class A common stock at such holder’s election, provided that as a result of such conversion, such holder and all other persons or entities whose beneficial ownership of Class A common stock would be aggregated with the shares of Class A common stock held by the holder for purposes of Section 13(d) of the Exchange Act, and the applicable rules and regulations thereunder, would not beneficially own in excess of 4.9% of any class of our securities registered under the Exchange Act. Accordingly, the holders of a majority of the outstanding shares of Class A common stock entitled to vote in any election of directors can elect all of the directors standing for election, If they so choose, other than any directors that holders of any preferred stock we may issue may be entitled to elect.
Holders of our common stock are entitled to receive proportionately any dividends as may be declared by our board of directors, subject to any preferential dividend rights of any series of preferred stock that we may designate and issue in the future, and to the requirements of law.
In the event of our liquidation or dissolution, the holders of our common stock are entitled to receive proportionately our net assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of our common stock have no preemptive, subscription, redemption or conversion rights. Our outstanding shares of common stock are validly issued, fully paid and nonassessable. The rights, preferences and privileges of holders of Class A common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.
Preferred Stock
Under the terms of our Certificate of Incorporation, our board of directors is authorized to direct us to issue shares of preferred stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.
The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from seeking to acquire, a majority of our outstanding voting stock.
Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws
Some provisions of Delaware law, our Certificate of Incorporation and our Bylaws could make the following transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions which provide for payment of a premium over the market price for our shares.
Undesignated Preferred Stock
The ability of our board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with voting or other rights or preferences as designated by our board of directors could impede the success of any attempt to change control of us. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control or management of the Company.
Stockholder Meetings
Our Bylaws provide that a special meeting of stockholders may be called only by our board of directors, chairperson of the board, chief executive officer or president (in the absence of a chief executive officer).
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our Bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors.
Elimination of Stockholder Action by Written Consent
Our Certificate of Incorporation eliminates the right of stockholders to act by written consent without a meeting.
Staggered Board
In accordance with our Certificate of Incorporation, and subject to the rights of holders of any series of preferred stock to elect directors, our board of directors is divided into three classes. Each class shall consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire board of directors. The directors in each class will serve for a three-year term, with one class being elected each year by our stockholders. Our Certificate of Incorporation and Bylaws provide that the authorized number of directors may be changed only by resolution of the board of directors. This system of electing and removing directors may delay or prevent a change of management or a change in control of our company and tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Removal of Directors
Our Certificate of Incorporation provides that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of the holders of at least two-thirds in voting power of the outstanding shares of stock entitled to vote in the election of directors.
Stockholders Not Entitled to Cumulative Voting
Our Certificate of Incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, a plurality of the votes cast by holders of shares of our Class A common stock shall be sufficient to elect all of the directors standing for election, if they choose, other than any directors that holders of our preferred stock may be entitled to elect.
Delaware Anti-Takeover Statute
We are subject to Section 203 of the DGCL, which prohibits persons deemed to be “interested stockholders” from engaging in a “business combination” with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.
Choice of Forum
Our Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative form, the Court of Chancery of the State of Delaware is the sole and exclusive forum for: (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, employees or stockholders; (3) any action asserting a claim against us arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware; or (4) any action asserting a claim governed by the internal affairs doctrine. Under our Certificate of Incorporation, this exclusive forum provision does not apply to suits brought to enforce any liability or duty created by the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. If and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Our Certificate of Incorporation further provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Our Certificate of Incorporation also provides that any person or entity purchasing or otherwise acquiring or holding any interest in shares of our capital stock shall be deemed to have notice of and to have consented to this choice of forum provision. It is possible that a court of law could rule that the choice of forum provision contained in our Certificate of Incorporation is inapplicable or unenforceable if it is challenged in a proceeding or otherwise.
Amendment of Charter Provisions
The amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue preferred stock and the provision prohibiting cumulative voting, would require approval by holders of at least two-thirds in voting power of the outstanding shares of stock entitled to vote thereon.
The provisions of Delaware law, our Certificate of Incorporation and our Bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit
temporary fluctuations in the market price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of our board and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.
Stock Exchange Listing
Our Class A common stock is listed on The Nasdaq Capital Market under the symbol “ELUT.”
DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we include in any applicable prospectus supplement or free writing prospectus, summarizes certain general terms and provisions of the debt securities that we may offer under this prospectus. When we offer to sell a particular series of debt securities, we will describe the specific terms of the series in a supplement to this prospectus. We will also indicate in the supplement to what extent the general terms and provisions described in this prospectus apply to a particular series of debt securities.
We may issue debt securities either separately, or together with, or upon the conversion or exercise of or in exchange for, other securities described in this prospectus. Debt securities may be our senior, senior subordinated or subordinated obligations and, unless otherwise specified in a supplement to this prospectus, the debt securities will be our direct, unsecured obligations and may be issued in one or more series.
The debt securities will be issued under an indenture between us and a trustee. We have summarized select portions of the indenture below. The summary is not complete. The form of the indenture has been filed as an exhibit to the registration statement and you should read the indenture for provisions that may be important to you. In the summary below, we have included references to the section numbers of the indenture so that you can easily locate these provisions. Capitalized terms used in the summary and not defined herein have the meanings specified in the indenture.
As used in this section only, “Elutia” “we,” “our” or “us” refer to Elutia Inc., excluding our subsidiary, unless expressly stated or the context otherwise requires.
General
The terms of each series of debt securities will be established by or pursuant to a resolution of our board of directors and set forth or determined in the manner provided in a resolution of our board of directors, in an officer’s certificate or by a supplemental indenture. (Section 2.2) The particular terms of each series of debt securities will be described in a prospectus supplement relating to such series (including any pricing supplement or term sheet).
We can issue an unlimited amount of debt securities under the indenture that may be in one or more series with the same or various maturities, at par, at a premium, or at a discount. (Section 2.1) We will set forth in a prospectus supplement (including any pricing supplement or term sheet) relating to any series of debt securities being offered, the aggregate principal amount and the following terms of the debt securities, if applicable:
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the title and ranking of the debt securities (including the terms of any subordination provisions);
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the price or prices (expressed as a percentage of the principal amount) at which we will sell the debt securities;
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any limit on the aggregate principal amount of the debt securities;
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the date or dates on which the principal of the securities of the series is payable;
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the rate or rates (which may be fixed or variable) per annum or the method used to determine the rate or rates (including any commodity, commodity index, stock exchange index or financial index) at which the debt securities will bear interest, the date or dates from which interest will accrue, the date or dates on which interest will commence and be payable and any regular record date for the interest payable on any interest payment date;
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the place or places where principal of, and interest, if any, on the debt securities will be payable (and the method of such payment), where the securities of such series may be surrendered for registration of transfer or exchange, and where notices and demands to us in respect of the debt securities may be delivered;
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the period or periods within which, the price or prices at which and the terms and conditions upon which we may redeem the debt securities;
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any obligation we have to redeem or purchase the debt securities pursuant to any sinking fund or analogous provisions or at the option of a holder of debt securities and the period or periods within which, the price or prices at which and in the terms and conditions upon which securities of the series shall be redeemed or purchased, in whole or in part, pursuant to such obligation;
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the dates on which and the price or prices at which we will repurchase debt securities at the option of the holders of debt securities and other detailed terms and provisions of these repurchase obligations;
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the denominations in which the debt securities will be issued, if other than denominations of $1,000 and any integral multiple thereof;
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whether the debt securities will be issued in the form of certificated debt securities or global debt securities;
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the portion of principal amount of the debt securities payable upon declaration of acceleration of the maturity date, if other than the principal amount;
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the currency of denomination of the debt securities, which may be United States Dollars or any foreign currency, and if such currency of denomination is a composite currency, the agency or organization, if any, responsible for overseeing such composite currency;
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the designation of the currency, currencies or currency units in which payment of principal of, premium and interest on the debt securities will be made;
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if payments of principal of, premium or interest on the debt securities will be made in one or more currencies or currency units other than that or those in which the debt securities are denominated, the manner in which the exchange rate with respect to these payments will be determined;
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the manner in which the amounts of payment of principal of, premium, if any, or interest on the debt securities will be determined, if these amounts may be determined by reference to an index based on a currency or currencies or by reference to a commodity, commodity index, stock exchange index or financial index;
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any provisions relating to any security provided for the debt securities;
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any addition to, deletion of or change in the Events of Default described in this prospectus or in the indenture with respect to the debt securities and any change in the acceleration provisions described in this prospectus or in the indenture with respect to the debt securities;
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any addition to, deletion of or change in the covenants described in this prospectus or in the indenture with respect to the debt securities;
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any depositaries, interest rate calculation agents, exchange rate calculation agents or other agents with respect to the debt securities;
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the provisions, if any, relating to conversion or exchange of any debt securities of such series, including if applicable, the conversion or exchange price and period, provisions as to whether conversion or exchange will be mandatory, the events requiring an adjustment of the conversion or exchange price and provisions affecting conversion or exchange;
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any other terms of the debt securities, which may supplement, modify or delete any provision of the indenture as it applies to that series, including any terms that may be required under applicable law or regulations or advisable in connection with the marketing of the securities; and
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whether any of our direct or indirect subsidiaries will guarantee the debt securities of that series, including the terms of subordination, if any, of such guarantees. (Section 2.2)
We may issue debt securities that provide for an amount less than their stated principal amount to be due and payable upon declaration of acceleration of their maturity pursuant to the terms of the indenture. We will provide you with information on certain U.S. federal income tax considerations and other special considerations applicable to any of these debt securities in the applicable prospectus supplement.
If we denominate the purchase price of any of the debt securities in a foreign currency or currencies or a foreign currency unit or units, or if the principal of and any premium and interest on any series of debt
securities is payable in a foreign currency or currencies or a foreign currency unit or units, we will provide you with information on the restrictions, elections, certain U.S. federal income tax considerations, specific terms and other information with respect to that issue of debt securities and such foreign currency or currencies or foreign currency unit or units in the applicable prospectus supplement.
Transfer and Exchange
Each debt security will be represented by either one or more global securities registered in the name of The Depository Trust Company, or the Depositary, or a nominee of the Depositary (we will refer to any debt security represented by a global debt security as a “book-entry debt security”), or a certificate issued in definitive registered form (we will refer to any debt security represented by a certificated security as a “certificated debt security”) as set forth in the applicable prospectus supplement. Except as set forth under the heading “Global Debt Securities and Book-Entry System” below, book-entry debt securities will not be issuable in certificated form.
Certificated Debt Securities. You may transfer or exchange certificated debt securities at any office we maintain for this purpose in accordance with the terms of the indenture. (Section 2.4) No service charge will be made for any transfer or exchange of certificated debt securities, but we may require payment of a sum sufficient to cover any tax or other governmental charge payable in connection with a transfer or exchange. (Section 2.7)
You may effect the transfer of certificated debt securities and the right to receive the principal of, premium and interest on certificated debt securities only by surrendering the certificate representing those certificated debt securities and either reissuance by us or the trustee of the certificate to the new holder or the issuance by us or the trustee of a new certificate to the new holder.
Global Debt Securities and Book-Entry System. Each global debt security representing book-entry debt securities will be deposited with, or on behalf of, the Depositary, and registered in the name of the Depositary or a nominee of the Depositary.
Covenants
We will set forth in the applicable prospectus supplement any restrictive covenants applicable to any issue of debt securities. (Article IV)
No Protection in the Event of a Change of Control
Unless we state otherwise in the applicable prospectus supplement, the debt securities will not contain any provisions which may afford holders of the debt securities protection in the event we have a change in control or in the event of a highly leveraged transaction (whether or not such transaction results in a change in control) which could adversely affect holders of debt securities.
Consolidation, Merger and Sale of Assets
We may not consolidate with or merge with or into, or convey, transfer or lease all or substantially all of our properties and assets to any person (a “successor person”) unless:
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we are the surviving corporation or the successor person (if other than Elutia) is a corporation organized and validly existing under the laws of any U.S. domestic jurisdiction and expressly assumes our obligations on the debt securities and under the indenture; and
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immediately after giving effect to the transaction, no Default or Event of Default, shall have occurred and be continuing.
Notwithstanding the above, any of our subsidiaries may consolidate with, merge into or transfer all or part of its properties to us. (Section 5.1)
Events of Default
“Event of Default” means with respect to any series of debt securities, any of the following:
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default in the payment of any interest upon any debt security of that series when it becomes due and payable, and continuance of such default for a period of 30 days (unless the entire amount of the payment is deposited by us with the trustee or with a paying agent prior to the expiration of the 30-day period);
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default in the payment of principal of any security of that series at its maturity;
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default in the performance or breach of any other covenant or warranty by us in the indenture (other than a covenant or warranty that has been included in the indenture solely for the benefit of a series of debt securities other than that series), which default continues uncured for a period of 60 days after we receive written notice from the trustee or Elutia and the trustee receive written notice from the holders of not less than 25% in principal amount of the outstanding debt securities of that series as provided in the indenture;
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certain voluntary or involuntary events of bankruptcy, insolvency or reorganization of Elutia;
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any other Event of Default provided with respect to debt securities of that series that is described in the applicable prospectus supplement. (Section 6.1)
No Event of Default with respect to a particular series of debt securities (except as to certain events of bankruptcy, insolvency or reorganization) necessarily constitutes an Event of Default with respect to any other series of debt securities. (Section 6.1) The occurrence of certain Events of Default or an acceleration under the indenture may constitute an event of default under certain indebtedness of ours or our subsidiaries outstanding from time to time.
We will provide the trustee written notice of any Default or Event of Default within 30 days of becoming aware of the occurrence of such Default or Event of Default, which notice will describe in reasonable detail the status of such Default or Event of Default and what action we are taking or propose to take in respect thereof. (Section 6.1)
If an Event of Default with respect to debt securities of any series at the time outstanding occurs and is continuing, then the trustee or the holders of not less than 25% in principal amount of the outstanding debt securities of that series may, by a notice in writing to us (and to the trustee if given by the holders), declare to be due and payable immediately the principal of (or, if the debt securities of that series are discount securities, that portion of the principal amount as may be specified in the terms of that series) and accrued and unpaid interest, if any, on all debt securities of that series. In the case of an Event of Default resulting from certain events of bankruptcy, insolvency or reorganization, the principal (or such specified amount) of and accrued and unpaid interest, if any, on all outstanding debt securities will become and be immediately due and payable without any declaration or other act on the part of the trustee or any holder of outstanding debt securities. At any time after a declaration of acceleration with respect to debt securities of any series has been made, but before a judgment or decree for payment of the money due has been obtained by the trustee, the holders of a majority in principal amount of the outstanding debt securities of that series may rescind and annul the acceleration if all Events of Default, other than the non-payment of accelerated principal and interest, if any, with respect to debt securities of that series, have been cured or waived as provided in the indenture. (Section 6.2) We refer you to the prospectus supplement relating to any series of debt securities that are discount securities for the particular provisions relating to acceleration of a portion of the principal amount of such discount securities upon the occurrence of an Event of Default.
The indenture provides that the trustee may refuse to perform any duty or exercise any of its rights or powers under the indenture unless the trustee receives indemnity satisfactory to it against any cost, liability or expense which might be incurred by it in performing such duty or exercising such right or power. (Section 7.1(e)) Subject to certain rights of the trustee, the holders of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to the trustee or exercising any trust or power conferred on the trustee with respect to the debt securities of that series. (Section 6.12)
No holder of any debt security of any series will have any right to institute any proceeding, judicial or otherwise, with respect to the indenture or for the appointment of a receiver or trustee, or for any remedy under the indenture, unless:
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that holder has previously given to the trustee written notice of a continuing Event of Default with respect to debt securities of that series; and
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the holders of not less than 25% in principal amount of the outstanding debt securities of that series have made written request, and offered indemnity or security satisfactory to the trustee, to the trustee to institute the proceeding as trustee, and the trustee has not received from the holders of not less than a majority in principal amount of the outstanding debt securities of that series a direction inconsistent with that request and has failed to institute the proceeding within 60 days. (Section 6.7)
Notwithstanding any other provision in the indenture, the holder of any debt security will have an absolute and unconditional right to receive payment of the principal of, premium and any interest on that debt security on or after the due dates expressed in that debt security and to institute suit for the enforcement of payment. (Section 6.8)
The indenture requires us, within 120 days after the end of our fiscal year, to furnish to the trustee a statement as to compliance with the indenture. (Section 4.3) If a Default or Event of Default occurs and is continuing with respect to the securities of any series and if it is known to a responsible officer of the trustee, the trustee shall mail to each Securityholder of the securities of that series notice of a Default or Event of Default within 90 days after it occurs or, if later, after a responsible officer of the trustee has knowledge of such Default or Event of Default. The indenture provides that the trustee may withhold notice to the holders of debt securities of any series of any Default or Event of Default (except in payment on any debt securities of that series) with respect to debt securities of that series if the trustee determines in good faith that withholding notice is in the interest of the holders of those debt securities. (Section 7.5)
Modification and Waiver
We and the trustee may modify, amend or supplement the indenture or the debt securities of any series without the consent of any holder of any debt security:
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to cure any ambiguity, defect or inconsistency;
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to comply with covenants in the indenture described above under the heading “Consolidation, Merger and Sale of Assets”;
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to provide for uncertificated securities in addition to or in place of certificated securities;
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to add guarantees with respect to debt securities of any series or secure debt securities of any series;
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to surrender any of our rights or powers under the indenture;
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to add covenants or events of default for the benefit of the holders of debt securities of any series;
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to comply with the applicable procedures of the applicable depositary;
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to make any change that does not adversely affect the rights of any holder of debt securities;
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to provide for the issuance of and establish the form and terms and conditions of debt securities of any series as permitted by the indenture;
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to effect the appointment of a successor trustee with respect to the debt securities of any series and to add to or change any of the provisions of the indenture to provide for or facilitate administration by more than one trustee; or
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to comply with requirements of the SEC in order to effect or maintain the qualification of the indenture under the Trust Indenture Act. (Section 9.1)
We may also modify and amend the indenture with the consent of the holders of at least a majority in principal amount of the outstanding debt securities of each series affected by the modifications or amendments. We may not make any modification or amendment without the consent of the holders of each affected debt security then outstanding if that amendment will:
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reduce the amount of debt securities whose holders must consent to an amendment, supplement or waiver;
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reduce the rate of or extend the time for payment of interest (including default interest) on any debt security;
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reduce the principal of or premium on or change the fixed maturity of any debt security or reduce the amount of, or postpone the date fixed for, the payment of any sinking fund or analogous obligation with respect to any series of debt securities;
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reduce the principal amount of discount securities payable upon acceleration of maturity;
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waive a default in the payment of the principal of, premium or interest on any debt security (except a rescission of acceleration of the debt securities of any series by the holders of at least a majority in aggregate principal amount of the then outstanding debt securities of that series and a waiver of the payment default that resulted from such acceleration);
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make the principal of or premium or interest on any debt security payable in currency other than that stated in the debt security;
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make any change to certain provisions of the indenture relating to, among other things, the right of holders of debt securities to receive payment of the principal of, premium and interest on those debt securities and to institute suit for the enforcement of any such payment and to waivers or amendments; or
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waive a redemption payment with respect to any debt security. (Section 9.3)
Except for certain specified provisions, the holders of at least a majority in principal amount of the outstanding debt securities of any series may on behalf of the holders of all debt securities of that series waive our compliance with provisions of the indenture. (Section 9.2) The holders of a majority in principal amount of the outstanding debt securities of any series may on behalf of the holders of all the debt securities of such series waive any past default under the indenture with respect to that series and its consequences, except a default in the payment of the principal of, premium or any interest on any debt security of that series; provided, however, that the holders of a majority in principal amount of the outstanding debt securities of any series may rescind an acceleration and its consequences, including any related payment default that resulted from the acceleration. (Section 6.13)
Defeasance of Debt Securities and Certain Covenants in Certain Circumstances
Legal Defeasance. The indenture provides that, unless otherwise provided by the terms of the applicable series of debt securities, we may be discharged from any and all obligations in respect of the debt securities of any series (subject to certain exceptions). We will be so discharged upon the irrevocable deposit with the trustee, in trust, of money and/or U.S. government obligations or, in the case of debt securities denominated in a single currency other than U.S. Dollars, government obligations of the government that issued or caused to be issued such currency, that, through the payment of interest and principal in accordance with their terms, will provide money or U.S. government obligations in an amount sufficient in the opinion of a nationally recognized firm of independent public accountants or investment bank to pay and discharge each installment of principal, premium and interest on and any mandatory sinking fund payments in respect of the debt securities of that series on the stated maturity of those payments in accordance with the terms of the indenture and those debt securities.
This discharge may occur only if, among other things, we have delivered to the trustee an opinion of counsel stating that we have received from, or there has been published by, the United States Internal Revenue Service a ruling or, since the date of execution of the indenture, there has been a change in the applicable United States federal income tax law, in either case to the effect that, and based thereon such opinion shall confirm that, the holders of the debt securities of that series will not recognize income, gain or loss for United States federal income tax purposes as a result of the deposit, defeasance and discharge and will be subject to United States federal income tax on the same amounts and in the same manner and at the same times as would have been the case if the deposit, defeasance and discharge had not occurred. (Section 8.3)
Defeasance of Certain Covenants. The indenture provides that, unless otherwise provided by the terms of the applicable series of debt securities, upon compliance with certain conditions:
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we may omit to comply with the covenant described under the heading “Consolidation, Merger and Sale of Assets” and certain other covenants set forth in the indenture, as well as any additional covenants which may be set forth in the applicable prospectus supplement; and
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any omission to comply with those covenants will not constitute a Default or an Event of Default with respect to the debt securities of that series (“covenant defeasance”).
The conditions include:
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depositing with the trustee money and/or U.S. government obligations or, in the case of debt securities denominated in a single currency other than U.S. Dollars, government obligations of the government that issued or caused to be issued such currency, that, through the payment of interest and principal in accordance with their terms, will provide money in an amount sufficient in the opinion of a nationally recognized firm of independent public accountants or investment bank to pay and discharge each installment of principal of, premium and interest on and any mandatory sinking fund payments in respect of the debt securities of that series on the stated maturity of those payments in accordance with the terms of the indenture and those debt securities; and
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delivering to the trustee an opinion of counsel to the effect that the holders of the debt securities of that series will not recognize income, gain or loss for United States federal income tax purposes as a result of the deposit and related covenant defeasance and will be subject to United States federal income tax on the same amounts and in the same manner and at the same times as would have been the case if the deposit and related covenant defeasance had not occurred. (Section 8.4)
No Personal Liability of Directors, Officers, Employees or Securityholders
None of our past, present or future directors, officers, employees or securityholders, as such, will have any liability for any of our obligations under the debt securities or the indenture or for any claim based on, or in respect or by reason of, such obligations or their creation. By accepting a debt security, each holder waives and releases all such liability. This waiver and release is part of the consideration for the issue of the debt securities. However, this waiver and release may not be effective to waive liabilities under U.S. federal securities laws, and it is the view of the SEC that such a waiver is against public policy.
Governing Law
The indenture and the debt securities, including any claim or controversy arising out of or relating to the indenture or the securities, will be governed by the laws of the State of New York.
The indenture will provide that we, the trustee and the holders of the debt securities (by their acceptance of the debt securities) irrevocably waive, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to the indenture, the debt securities or the transactions contemplated thereby.
The indenture will provide that any legal suit, action or proceeding arising out of or based upon the indenture or the transactions contemplated thereby may be instituted in the federal courts of the United States of America located in the City of New York or the courts of the State of New York in each case located in the City of New York, and we, the trustee and the holder of the debt securities (by their acceptance of the debt securities) irrevocably submit to the non-exclusive jurisdiction of such courts in any such suit, action or proceeding. The indenture will further provide that service of any process, summons, notice or document by mail (to the extent allowed under any applicable statute or rule of court) to such party’s address set forth in the indenture will be effective service of process for any suit, action or other proceeding brought in any such court. The indenture will further provide that we, the trustee and the holders of the debt securities (by their acceptance of the debt securities) irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the courts specified above and irrevocably and unconditionally waive and agree not to plead or claim any such suit, action or other proceeding has been brought in an inconvenient forum. (Section 10.10).
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of shares of our common stock or preferred stock or of debt securities. We may issue warrants independently or together with other securities, and the warrants may be attached to or separate from any offered securities. Each series of warrants will be issued under a separate warrant agreement to be entered into between us and the investors or a warrant agent. The following summary of material provisions of the warrants and warrant agreements are subject to, and qualified in their entirety by reference to, all the provisions of the warrant agreement and warrant certificate applicable to a particular series of warrants. The terms of any warrants offered under a prospectus supplement may differ from the terms described below. We urge you to read the applicable prospectus supplement and any related free writing prospectus, as well as the complete warrant agreements and warrant certificates that contain the terms of the warrants.
The particular terms of any issue of warrants will be described in the prospectus supplement relating to the issue. Those terms may include:
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the number of shares of common stock or preferred stock purchasable upon the exercise of warrants to purchase such shares and the price at which such number of shares may be purchased upon such exercise;
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the designation, stated value and terms (including, without limitation, liquidation, dividend, conversion and voting rights) of the series of preferred stock purchasable upon exercise of warrants to purchase preferred stock;
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the principal amount of debt securities that may be purchased upon exercise of a debt warrant and the exercise price for the warrants, which may be payable in cash, securities or other property;
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the date, if any, on and after which the warrants and the related debt securities, preferred stock or common stock will be separately transferable;
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the terms of any rights to redeem or call the warrants;
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the date on which the right to exercise the warrants will commence and the date on which the right will expire;
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a discussion of certain United States federal income tax considerations applicable to the warrants; and
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any additional terms of the warrants, including terms, procedures, and limitations relating to the exchange, exercise and settlement of the warrants.
Holders of equity warrants will not be entitled:
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to vote, consent or receive dividends;
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receive notice as shareholders with respect to any meeting of shareholders for the election of our directors or any other matter; or
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exercise any rights as shareholders of Elutia.
Each warrant will entitle its holder to purchase the principal amount of debt securities or the number of shares of preferred stock or common stock at the exercise price set forth in, or calculable as set forth in, the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time up to the specified time on the expiration date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become void.
A holder of warrant certificates may exchange them for new warrant certificates of different denominations, present them for registration of transfer and exercise them at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement. Until any warrants to purchase debt securities are exercised, the holder of the warrants will not have any rights of holders of the debt securities that can be purchased upon exercise, including any rights to receive payments of principal, premium or interest on the underlying debt securities or to enforce covenants in the applicable indenture.
Until any warrants to purchase common stock or preferred stock are exercised, the holders of the warrants will not have any rights of holders of the underlying common stock or preferred stock, including any rights to receive dividends or payments upon any liquidation, dissolution or winding up on the common stock or preferred stock, if any.
DESCRIPTION OF UNITS
We may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series. We may evidence each series of units by unit certificates that we will issue under a separate agreement. We may enter into unit agreements with a unit agent. Each unit agent will be a bank or trust company that we select. We will indicate the name and address of the unit agent in the applicable prospectus supplement relating to a particular series of units.
The following description, together with the additional information included in any applicable prospectus supplement, summarizes the general features of the units that we may offer under this prospectus. You should read any prospectus supplement and any free writing prospectus that we may authorize to be provided to you related to the series of units being offered, as well as the complete unit agreements that contain the terms of the units. Specific unit agreements will contain additional important terms and provisions and we will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from another report that we file with the SEC, the form of each unit agreement relating to units offered under this prospectus.
If we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including, without limitation, the following, as applicable:
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the title of the series of units;
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identification and description of the separate constituent securities comprising the units;
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the price or prices at which the units will be issued;
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the date, if any, on and after which the constituent securities comprising the units will be separately transferable;
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a discussion of certain United States federal income tax considerations applicable to the units; and
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any other terms of the units and their constituent securities.
PLAN OF DISTRIBUTION
We may sell the securities from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or a combination of these methods or through underwriters or dealers, through agents and/or directly to one or more purchasers. The securities may be distributed from time to time in one or more transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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at negotiated prices.
Each time that we sell securities covered by this prospectus, we will provide a prospectus supplement or supplements that will describe the method of distribution and set forth the terms and conditions of the offering of such securities, including the offering price of the securities and the proceeds to us, if applicable.
Offers to purchase the securities being offered by this prospectus may be solicited directly. Agents may also be designated to solicit offers to purchase the securities from time to time. Any agent involved in the offer or sale of our securities will be identified in a prospectus supplement.
If a dealer is utilized in the sale of the securities being offered by this prospectus, the securities will be sold to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the time of resale.
If an underwriter is utilized in the sale of the securities being offered by this prospectus, an underwriting agreement will be executed with the underwriter at the time of sale and the name of any underwriter will be provided in the prospectus supplement that the underwriter will use to make resales of the securities to the public. In connection with the sale of the securities, we or the purchasers of securities for whom the underwriter may act as agent, may compensate the underwriter in the form of underwriting discounts or commissions. The underwriter may sell the securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters and/or commissions from the purchasers for which they may act as agent. Unless otherwise indicated in a prospectus supplement, an agent will be acting on a best efforts basis and a dealer will purchase securities as a principal, and may then resell the securities at varying prices to be determined by the dealer.
Any compensation paid to underwriters, dealers or agents in connection with the offering of the securities, and any discounts, concessions or commissions allowed by underwriters to participating dealers will be provided in the applicable prospectus supplement. Underwriters, dealers and agents participating in the distribution of the securities may be deemed to be underwriters within the meaning of the Securities Act, and any discounts and commissions received by them and any profit realized by them on resale of the securities may be deemed to be underwriting discounts and commissions. We may enter into agreements to indemnify underwriters, dealers and agents against civil liabilities, including liabilities under the Securities Act, or to contribute to payments they may be required to make in respect thereof and to reimburse those persons for certain expenses.
Any Class A common stock will be listed on the Nasdaq Capital Market, but any other securities may or may not be listed on a national securities exchange. To facilitate the offering of securities, certain persons participating in the offering may engage in transactions that stabilize, maintain or otherwise affect the price of the securities. This may include over-allotments or short sales of the securities, which involve the sale by persons participating in the offering of more securities than were sold to them. In these circumstances, these persons would cover such over-allotments or short positions by making purchases in the open market or by exercising their over-allotment option, if any. In addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating in the offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise prevail in the open market. These transactions may be discontinued at any time.
We may engage in at the market offerings into an existing trading market in accordance with Rule 415(a)(4) under the Securities Act. In addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings of stock, and may use securities received from us in settlement of those derivatives to close out any related open borrowings of stock. The third party in such sale transactions will be an underwriter and, if not identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective amendment). In addition, we may otherwise loan or pledge securities to a financial institution or other third party that in turn may sell the securities short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.
The specific terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.
The underwriters, dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business for which they receive compensation.
LEGAL MATTERS
Kilpatrick Townsend & Stockton LLP, Atlanta, Georgia, will pass upon certain legal matters relating to the issuance and sale of the securities offered herby on behalf of Elutia Inc. Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that we will name in the applicable prospectus supplement.
EXPERTS
The financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December 31, 2024 have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as described in Note 2 to the financial statements) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The information in this prospectus is not complete and may be changed. Class A common stock offered hereby may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell nor does it seek an offer to buy any securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, dated March 18, 2025
PROSPECTUS
ELUTIA INC.
Up to $50,000,000
Shares of Class A Common Stock
We have entered into a Controlled Equity OfferingSM Sales Agreement, or the sales agreement, with Cantor Fitzgerald & Co., or the Agent, relating to the sale of shares of our Class A common stock, par value $0.001 per share, offered by this prospectus. In accordance with the terms of the sales agreement, under this prospectus we may offer and sell up to $50.0 million of shares of our Class A common stock from time to time through or to the Agent, as sales agent or principal.
Our Class A common stock is listed on the Nasdaq Capital Market under the symbol “ELUT.” On March 17, 2025, the last reported sale price of the Class A common stock on the Nasdaq Capital Market was $3.20 per share.
Sales of our Class A common stock, if any, under this prospectus may be made by any method permitted by law that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or the Securities Act. The Agent is not required to sell any specific number or dollar amount of shares of our Class A common stock. The Agent will use commercially reasonable efforts, consistent with its normal sales and trading practices, to solicit offers to purchase the Class A common stock under the terms and subject to the conditions set forth in the sales agreement. There is no arrangement for funds to be received in any escrow, trust or similar arrangement. The net proceeds from any sales under this prospectus will be used as described under the section entitled “Use of Proceeds.”
The Agent will be entitled to compensation at a commission rate equal to 3.0% of the gross proceeds of shares sold under the sales agreement. In connection with the sale of our Class A common stock on our behalf, the Agent will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of the Agent will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to the Agent with respect to certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended, or the Exchange Act. See “Plan of Distribution” beginning on page 15 for additional information regarding the compensation to be paid to the Agent.
INVESTING IN OUR SECURITIES INVOLVES RISK. BEFORE BUYING ANY OF OUR CLASS A COMMON STOCK, YOU SHOULD REVIEW CAREFULLY THE “RISK FACTORS” BEGINNING ON PAGE 5 OF THIS PROSPECTUS AND THE DOCUMENTS INCORPORATED BY REFERENCE HEREIN.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of our Class A common stock or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
Cantor
The date of this prospectus is March , 2025.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
This prospectus relates to part of a registration statement on Form S-3 that we have filed with the Securities and Exchange Commission, or SEC, utilizing a “shelf” registration process. Under the registration statement, we may, from time to time, sell any combination of the securities described in the registration statement. Under this prospectus, we may offer and sell shares of our Class A common stock having an aggregate offering price of up to $50.0 million from time to time at prices and on terms to be determined by market conditions at the time of the offering.
Before buying any of the Class A common stock that we are offering, we urge you to carefully read this prospectus and all of the information incorporated by reference in this prospectus, as well as the additional information described under the headings “Where You Can Find More Information; Incorporation by Reference”. These documents contain important information that you should consider when making your investment decision.
To the extent there is a conflict between the information contained in this prospectus, on the one hand, and the information contained in any document incorporated by reference in this prospectus that was filed with the SEC before the date of this prospectus, on the other hand, you should rely on the information in this prospectus. If any statement in one of these documents is inconsistent with a statement in another document having a later date — for example, a document incorporated by reference in this prospectus filed after the date of this prospectus — the statement in the document having the later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein or as an exhibit to the registration statement of which this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreement, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
Neither we nor the Agent have authorized anyone to provide you with any information or to make any representation, other than those contained or incorporated by reference in this prospectus. Neither we nor the Agent take any responsibility for, and provide no assurance as to the reliability of, any other information that others may give you. You should assume that the information appearing in this prospectus and the documents incorporated by reference in this prospectus is accurate only as of the date of those respective documents. Our business, financial condition, results of operations and prospects may have changed since those dates.
We are offering to sell, and seeking offers to buy, our Class A common stock only in jurisdictions where offers and sales are permitted. The distribution of this prospectus and the offering of the Class A common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the Class A common stock and the distribution of this prospectus outside the United States.
Market data and industry statistics used throughout this prospectus and the documents incorporated by reference into this prospectus are based on independent industry publications, reports by market research firms and other published independent sources. Although we believe these sources are credible, we have not independently verified the data or information obtained from these sources. Accordingly, investors should not place undue reliance on this information. By including such market data and information, we do not undertake a duty to update or provide that data in the future.
When used in this prospectus, the terms “company,” “Elutia,” “we,” “our” and “us” refer to Elutia Inc. (formerly known as Aziyo Biologics, Inc.) and its subsidiaries, unless otherwise specified or unless the context requires otherwise.
This prospectus and the documents incorporated by reference into this prospectus include trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included or incorporated by reference into this prospectus are the property of their respective owners.
We use our trademarks and our logo, in this prospectus and the documents incorporated by reference. This prospectus and the documents incorporated by reference also include trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this prospectus appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.
SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference into this prospectus may include forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend for such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, referred to as the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, referred to as the Exchange Act. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Without limiting the foregoing, the words “aim,” “believe,” “may,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “opportunity,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are not a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.
These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to several known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following:
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our ability to successfully commercialize, market and sell our EluPro® antibacterial envelope device;
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our ability to continue as a going concern;
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our ability to achieve or sustain profitability;
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the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance;
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our ability to defend against the various lawsuits related to our recall of a single lot of Fiber Viable Bone Matrix, or FiberCel, our recall of a single lot of another viable bone matrix, or VBM, product and the market withdrawal of all of our viable bone matrix products, and to avoid a material financial consequence from such lawsuits;
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our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and VBM liabilities;
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the continued and future acceptance of our products by the medical community;
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our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings;
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our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales;
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our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business;
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our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business;
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physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products;
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our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do;
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pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability;
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our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration, or FDA, and comparable foreign authorities for our products and product candidates; and
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our ability to obtain, maintain and adequately protect our intellectual property rights.
Further information about these and other important factors that could materially affect the Company, including our results of operations, financial condition and stock price, is contained under the heading “Risk Factors” starting on page 5 of this prospectus, in Part I, Item 1A, “Risk Factors” and Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the SEC, each of which filings are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of our website at https://investors.elutia.com/financials/sec-filings.
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. In addition, the timing and occurrence or non-occurrence of events may be subject to circumstances beyond our control.
Furthermore, we routinely evaluate opportunities to expand through acquisitions and conduct due diligence activities in connection with such opportunities. As a result, acquisition discussions and, in some cases, negotiations, may take place at any time, and acquisitions involving cash or our debt or equity securities may occur.
You should not place undue reliance on the forward-looking statements contained in, or incorporated by reference into, this prospectus, which speak only as of the date of this prospectus. We do not assume any obligation to revise or update these forward-looking statements except as may be required by law.
PROSPECTUS SUMMARY
This summary highlights selected information about us, this offering and information appearing elsewhere in this prospectus and in the documents we incorporate by reference. This summary is not complete and does not contain all of the information you should consider before investing in our securities. Before making an investment decision, to fully understand this offering and its consequences to you, you should carefully read this entire prospectus, including “Risk Factors” beginning on page 5 of this prospectus and the financial statements and related notes and the other information that we incorporate by reference into this prospectus.
Our Company
At Elutia, our mission is to humanize medicine so that patients can thrive without compromise. As a commercial-stage company, we seek to leverage our unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. These complications include infection, device migration, erosion, implant rejection, non-union of implants, fibrosis and scar formation. Our products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation and avoiding complications associated with medical device implants, such as scar tissue formation, capsular contraction, erosion, migration and infection. We currently focus on our priority markets — Device Protection and Women’s Health.
In Device Protection, we sell EluPro®, a unique bioenvelope designed to mitigate complications associated with the implantation of electronic medical devices such as pacemakers, internal defibrillators and neurostimulation devices. Complications addressed by EluPro include infection, device migration and erosion. The bioenvelope features a biomatrix comprised of extracellular matrix, which supports healthy wound healing and may facilitate re-operative procedures by reducing scar formation and fibrosis. Additionally, EluPro is embedded with the powerful antibiotics rifampin and minocycline, which are gradually released into the surrounding tissue over several weeks post-implantation to provide antimicrobial protection. EluPro is the only drug-eluting biomatrix offering in the U.S. implantable electronic device protection market. Alongside EluPro, we market the CanGaroo® bioenvelope, our first generation product, which uses the same biomatrix but does not contain antibiotics.
In Women’s Health, we have developed both patented and proprietary technologies, culminating in the creation of SimpliDerm® — a novel biological matrix that leverages the inherent science of natural healing processes. SimpliDerm’s design uses human-based hydrated acellular dermal matrix with heightened structural integrity and superior handling capabilities, which may mitigate inflammation and enhance tissue incorporation, leading to a better healing experience as compared to other human acellular dermal matrices, both lyophilized and pre-hydrated. We believe that these acellular dermal matrices represent an ideal choice for tissue repair and reconstruction, finding applications in fields such as breast reconstruction, sports medicine, hernia repair and trauma reconstruction.
We also sell legacy products into the Cardiovascular market. In Cardiovascular, we sell our specialized porcine small intestine submucosa, which is based on the same biomatrix used in EluPro and CanGaroo, for use as an intracardiac and vascular patch as well as for pericardial reconstruction. In addition, our TYKE product is designed for use in the neonatal patient population. These cardiovascular products are sold in the United States through an exclusive distribution agreement with LeMaitre Vascular, Inc. This agreement also provided LeMaitre with an option to acquire the Cardiovascular product line through March 2026.
We have a well-established and scalable internal manufacturing facility along with our corporate headquarters and other administrative location. Our Roswell, Georgia location is our processing, production and distribution facility for all of our implantable electronic Device Protection and Cardiovascular products. Our Silver Spring, Maryland location is our headquarters and functions as a research and development and corporate support center. Our San Diego, California location provides additional administrative oversight and support. With the sale of our Orthobiologics business in November 2023, we no longer operate our former Richmond, California human tissue processing and distribution facility; however, we continue to have a contract manufacturing relationship with the purchaser under which we receive SimpliDerm. In March 2025 we signed a lease for an additional facility in Gaithersburg, Maryland for purposes of, among other things, the future internal production of current and future Women’s Health products.
We have incurred significant operating losses since our inception. We expect our losses to continue for the foreseeable future and these losses will continue to have an adverse effect on our financial position. For the year ended December 31, 2024, we had a net loss of $53.9 million and as of December 31, 2024, we had an accumulated deficit of $229.6 million. Because of the numerous risks and uncertainties associated with our commercialization and development efforts, we are unable to predict when we will become profitable, and we may never become profitable. Our inability to achieve and then maintain profitability would negatively affect our business, financial condition, results of operations and cash flows.
Corporate Information
We were incorporated under the laws of the State of Delaware on August 6, 2015 under the name Aziyo Biologics, Inc. On September 6, 2023, we changed our name to Elutia Inc. Our principal executive offices are located at 12510 Prosperity Drive, Suite 370, Silver Spring, MD 20904, and our telephone number is (240) 247-1170. We maintain a website at www.elutia.com. Information on the website is not incorporated by reference and is not a part of this prospectus.
THE OFFERING
Class A common stock offered by us
Shares of our Class A common stock having an aggregate offering price of up to $50.0 million.
Class A common stock to be outstanding immediately after this offering
Up to 52,275,618 shares, assuming the sale of $50.0 million of shares of our Class A common stock in this offering at a public offering price of $3.18 per share, which was the closing price of our Class A common stock on the Nasdaq Capital Market on March 14, 2025. The actual number of shares issued in this offering will vary depending on how many shares of our Class A common stock we choose to sell and the prices at which such sales occur.
Class B common stock to be outstanding immediately after this offering
4,313,406 shares.
“At the market offering” that may be made from time to time through or to, at our option, the Agent. See “Plan of Distribution” beginning on page 15 of this prospectus.
We currently expect to use the net proceeds from this offering for working capital and other general corporate purposes which may include product development and clinical research activities, current and additional sales personnel, commissions based on sales, capital expenditures related to expansion of production, administrative expenses, interest on outstanding debt and payments related to our revenue interest obligation, and/or resolution of claims related to the 2021 recall of our FiberCel fiber viable bone matrix and 2023 recall of our other viable bone matrix product. In addition, we may use a portion of the net proceeds for the acquisition of, or investment in, technologies, intellectual property or businesses that complement our business; however, we have no understandings, agreements or commitments to do so as of the date of this prospectus. Please see “Use of Proceeds” on page 8.
We have two classes of common stock: Class A common stock and Class B common stock. The rights of the holders of Class A common stock and Class B common stock are identical, except with respect to voting and conversion.
Each share of Class A common stock is entitled to one vote and shares of Class B common stock are non-voting, except as may be required by law.
Each share of Class B common stock may be converted into one share of Class A common stock at the option of its holder, subject to the ownership limitations provided for in our amended and restated certificate of incorporation.
See “Risk Factors” beginning on page 5 of this prospectus and in the documents incorporated by reference into this prospectus for a discussion of factors that you should read and consider before investing in our securities.
Our Class A common stock is listed on The Nasdaq Capital Market under the symbol “ELUT”.
Equiniti Trust Company, LLC
The number of shares of Class A common stock to be outstanding after this offering is based on 36,552,348 shares of our Class A common stock and 4,313,406 shares of our Class B common stock outstanding at March 13, 2025 and excludes the following:
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4,778,326 shares of Class A common stock issuable upon exercise of prefunded warrants outstanding at an exercise price of $0.001 per share;
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187,969 shares of Class A common stock issuable upon exercise of warrants outstanding at an exercise price of $6.65 per share;
•
1,342,766 shares of Class A common stock reserved for issuance upon the settlement of outstanding restricted stock units;
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3,220,991 shares of Class A common stock reserved for issuance upon the exercise of outstanding stock options with a weighted average exercise price of $5.23 per share;
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1,724,986 shares of Class A common stock reserved and available for issuance under the Elutia Inc. Amended and Restated 2020 Incentive Award Plan; and
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791,675 shares of Class A common stock reserved and available for issuance under the Elutia Inc. 2020 Employee Stock Purchase Plan.
RISK FACTORS
Investing in our securities involves risk. Before deciding whether to invest in our securities, you should carefully consider the risk factors we describe in this prospectus or in any report incorporated by reference into this prospectus, including our most Annual Report on Form 10-K, any Quarterly Report on Form 10-Q and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act, and the risk factors and other information contained in any applicable prospectus supplement and any applicable free writing prospectus. Although we discuss key risks in those risk factor descriptions, additional risks not currently known to us or that we currently deem immaterial also may impair our business. Our subsequent filings with the SEC may contain amended and updated discussions of significant risks. We cannot predict future risks or estimate the extent to which they may affect our financial performance.
Risks Related to this Offering and our Securities
Management will have broad discretion as to the use of the proceeds from this offering, and we may not use the proceeds effectively.
Our management will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our Class A common stock. Our failure to apply these funds effectively could have a material adverse effect on our business and cause the price of our Class A common stock to decline.
You may experience future dilution as a result of future equity offerings and other issuances of our Class A common stock or other securities. In addition, this offering and future equity offerings and other issuances of our Class A common stock or other securities may adversely affect our Class A common stock price.
In order to raise additional capital, we may in the future offer additional shares of our Class A common stock or other securities convertible into or exchangeable for our Class A common stock at prices that may not be the same as the price per share in this offering. We may not be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our Class A common stock or securities convertible into Class A common stock in future transactions may be higher or lower than the price per share in this offering. You will incur dilution upon exercise of any outstanding stock options, warrants or upon the issuance of shares of Class A common stock under our stock incentive programs. In addition, the sale of shares in this offering and any future sales of a substantial number of shares of our Class A common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our Class A common stock. We cannot predict the effect, if any, that market sales of those shares of Class A common stock or the availability of those shares of Class A common stock for sale will have on the market price of our Class A common stock.
You may experience immediate and substantial dilution in the book value per share of the Class A common stock you purchase.
Depending on the prices at which sales of Class A common stock are made in this offering, and the numbers of shares sold at various prices, you may suffer immediate and substantial dilution with respect to the net tangible book value of the Class A common stock you purchase in this offering. Assuming that an aggregate of 15,723,270 shares of our Class A common stock are sold at a price of $3.18 per share pursuant to this prospectus, which was the last reported sale price of our Class A common stock on the Nasdaq Capital Market on March 14, 2025, for aggregate gross proceeds of approximately $50.0 million, and after deducting the estimated offering-related expenses payable by us, our as adjusted net tangible book value as of December 31, 2024 would have been approximately $(6.5) million, or $(0.13) per share of Class A common stock. This amount represents an immediate increase in the adjusted net tangible book value of $1.42 per share of our Class A common stock to our existing stockholders and an immediate dilution in net tangible book value of $3.31 per share to the investors purchasing shares of our Class A common stock in this offering. See “Dilution” for a more detailed discussion of the dilution you may incur in connection with this offering.
An active trading market for our Class A common stock may not be developed or sustained.
Although our Class A common stock is listed on The Nasdaq Capital Market, the market for our Class A common stock has demonstrated varying levels of trading activity. Furthermore, the current level of trading may not be sustained in the future. The lack of an active market for our Class A common stock may impair investors’ ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable, may reduce the fair market value of their shares and may impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire additional intellectual property assets by using our shares as consideration.
Our stock price may be subject to substantial volatility, and stockholders may lose all or a substantial part of their investment.
Our Class A common stock currently trades on The Nasdaq Capital Market, or Nasdaq. There is limited public float, and trading volume historically has been low and sporadic. As a result, the market price for our Class A common stock may not necessarily be a reliable indicator of our fair market value. The price at which our Class A common stock trades may fluctuate as a result of a number of factors, including the number of shares available for sale in the market, quarterly variations in our operating results, actual or anticipated announcements of new releases by us or competitors, the gain or loss of significant customers, changes in the estimates of our operating performance, market conditions in our industry and the economy as a whole.
Because we do not anticipate paying any cash dividends on our Class A common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
We have never paid or declared any cash dividends on our Class A common stock. We currently intend to retain earnings, if any, to finance the growth and development of our business and we do not anticipate paying any cash dividends in the foreseeable future. As a result, only appreciation of the price of our Class A common stock will provide a return to our stockholders.
Our failure to maintain compliance with the Nasdaq Stock Market’s continued listing requirements could result in the delisting of our Class A common stock.
The listing of our Class A common stock on Nasdaq is subject to a number of conditions, including that the total market value of the company’s listed securities remain at or above a certain level. In the past, we have not maintained that required level and have been at risk of our Class A common stock being delisted by Nasdaq. Although we were able to regain compliance with the rule and avoid having our Class A common stock delisted, there is no guarantee that, in view of the volatility of our stock and other factors, we might not run afoul of the market value listing condition or other similar listing conditions in the future. The delisting of our Class A common stock would have a material adverse effect on the liquidity of the Class A common stock, and could have a material adverse effect on its price. Moreover, the threat of delisting could have similar consequences.
It is not possible to predict the actual number of shares we will sell under the sales agreement, or the gross proceeds resulting from those sales.
Subject to certain limitations in the sales agreement and compliance with applicable laws, we have the discretion to deliver a placement notice to the Agent at any time throughout the term of the sales agreement. The number of shares that are sold through the Agent after delivering a placement notice will fluctuate based on a number of factors, including the market price of our Class A common stock during the term of the sales agreement, the limits we set with the Agent in any applicable placement notice, and the demand for our Class A common stock during the term of the sales agreement. Because the price per share of each share sold will fluctuate during the term of the sales agreement, it is not currently possible to predict the number of shares that will be sold or the gross proceeds to be raised in connection with the sales of shares of common stock offered under this prospectus.
The Class A common stock offered hereby will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices.
Investors who purchase shares in this offering at different times will likely pay different prices, and so may experience different levels of dilution and different outcomes in their investment results. We will have
discretion, subject to market demand, to vary the timing, prices and numbers of shares sold in this offering. In addition, there is no minimum or maximum sales price for shares to be sold in this offering. Investors may experience a decline in the value of the shares they purchase in this offering as a result of sales made at prices lower than the prices they paid.
USE OF PROCEEDS
We may issue and sell shares of our Class A common stock having an aggregate offering price of up to $50.0 million from time to time. Because there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. There can be no assurance that, in the future, we will sell any shares under or fully utilize the sales agreement with the Agent as a source of financing.
We currently expect to use the net proceeds from this offering for working capital and other general corporate purposes which may include product development and clinical research activities, current and additional sales personnel, commissions based on sales, capital expenditures related to expansion of production, administrative expenses, interest on outstanding debt and payments related to our revenue interest obligation, and/or resolution of claims related to the 2021 recall of our FiberCel fiber viable bone matrix and 2023 recall of our other viable bone matrix product. In addition, we may use a portion of the net proceeds for the acquisition of, or investment in, technologies, intellectual property or businesses that complement our business; however, we have no understandings, agreements or commitments to do so as of the date of this prospectus.
Our management will have significant discretion and flexibility in applying the net proceeds from any sale of Class A common stock.
As of December 31, 2024, we had $23.5 million of indebtedness outstanding under our senior secured term loan facility with SWK Funding LLC, or SWK, as agent, and other lenders party thereto, and an exit fee liability to SWK of $0.9 million, with such balances being net of $0.5 million of unamortized discount and deferred financing costs. The weighted average interest rate of the indebtedness was 13.4% for the year ended December 31, 2024. See Notes 10 and 11 to the consolidated financial statements appearing in our Annual Report on Form 10-K for the year ended December 31, 2024, incorporated herein by reference, for further information on our loan facility agreement with SWK, and for a description of our revenue interest obligation to Ligand Pharmaceuticals, respectively.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our capital stock. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. Any future determination related to our dividend policy will be made at the discretion of our board of directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors the board of directors deems relevant, and subject to the restrictions contained in our existing senior, secured credit facility with SWK Funding LLC and any future financing instruments.
DILUTION
If you invest in our Class A common stock in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share and the as adjusted net tangible book value per share of our Class A common stock after this offering.
Our net tangible book value is the amount of our total tangible assets less our total liabilities. Net tangible book value per share is our net tangible book value divided by the number of shares of Class A and Class B common stock outstanding as of December 31, 2024. Our net tangible book value as of December 31, 2024 was approximately $(54.5) million, or $(1.55) per share of Class A and Class B common stock.
After giving effect to the assumed sale by us of shares of our Class A common stock having an aggregate offering price of $50.0 million at an assumed public offering price of $3.18 per share of Class A common stock, which was the last reported sale price of our Class A common stock on the Nasdaq Capital Market on March 14, 2025, and after deducting estimated commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of December 31, 2024 would have been approximately $(6.5) million, or $(0.13) per share of Class A and Class B common stock. This amount represents an immediate increase in the adjusted net tangible book value of $1.42 per share of our Class A and Class B common stock to our existing stockholders and an immediate dilution in net tangible book value of $3.31 per share to the investors purchasing Class A common stock in this offering.
The following table illustrates this dilution on a per share basis:
| |
Assumed offering price per share
|
|
|
|
|
|
|
|
|
|
$ |
3.18 |
|
|
| |
Net tangible book value per share as of December 31, 2024
|
|
|
|
$ |
(1.55) |
|
|
|
|
|
|
|
|
| |
Increase in net tangible book value per share as of December 31, 2024, attributable to investors
|
|
|
|
$ |
1.42 |
|
|
|
|
|
|
|
|
| |
As adjusted net tangible book value per share as of December 31, 2024, after giving effect to this offering
|
|
|
|
|
|
|
|
|
|
$ |
(0.13) |
|
|
| |
Dilution per share to investors
|
|
|
|
|
|
|
|
|
|
$ |
3.31 |
|
|
The shares sold in this offering, if any, will be sold from time to time at various prices. Assuming all of the Class A common stock in an aggregate amount of $50.0 million is sold in this offering at the assumed public offering price of $3.68 per share, a $0.50 increase in such offering price would increase our as adjusted net tangible book value (or decrease as adjusted net tangible book deficit) per share after this offering to $0.02 per share and the dilution to new investors to $3.66 per share, after deducting commissions and estimated offering expenses payable by us. A $0.50 decrease in the assumed public offering price would decrease our as adjusted net tangible book value per share after this offering to $(0.28) per share and the dilution to new investors to $2.96 per share, after deducting commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of shares that we offer in this offering, and other terms of this offering determined at the time of each offer and sale.
The number of shares of Class A common stock to be outstanding after this offering is based on 36,552,348 shares of our Class A common stock and 4,313,406 shares of our Class B common stock outstanding at March 13, 2025 and excludes the following:
•
4,778,326 shares of Class A common stock issuable upon exercise of prefunded warrants outstanding at an exercise price of $0.001 per share;
•
187,969 shares of Class A common stock issuable upon exercise of warrants outstanding at an exercise price of $6.65 per share;
•
1,342,766 shares of Class A common stock reserved for issuance upon the settlement of outstanding restricted stock units;
•
3,220,991 shares of Class A common stock reserved for issuance upon the exercise of outstanding stock options with a weighted average exercise price of $5.23 per share;
•
1,724,986 shares of Class A common stock reserved and available for issuance under the Elutia Inc. Amended and Restated 2020 Incentive Award Plan; and
•
791,675 shares of Class A common stock reserved and available for issuance under the Elutia Inc. 2020 Employee Stock Purchase Plan.
To the extent that any of these outstanding stock options or warrants are exercised, these restricted stock units vest or we issue additional shares under the Elutia Inc. Amended and Restated 2020 Incentive Award Plan, there may be further dilution to new investors. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
DESCRIPTION OF CAPITAL STOCK
Authorized Capital Stock
The following description of our restated certificate of incorporation (the “Certificate of Incorporation”), and amended and restated bylaws (the “Bylaws”) are summaries and are qualified in their entirety by reference to the full text of our Certificate of Incorporation and our Bylaws, each of which have been publicly filed with the Securities and Exchange Commission (the “SEC”). We encourage you to read the full text of our Certificate of Incorporation and our Bylaws and the applicable provisions of the Delaware General Corporation Law (the “DGCL”) for additional information.
Our authorized capital stock consists of 200,000,000 shares of Class A common stock, par value $0.001 per share, 20,000,000 shares of Class B common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share, all of which are undesignated.
Class A Common Stock and Class B Common Stock
Holders of our Class A common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An election of directors by our stockholders shall be determined by a plurality of the votes cast. Subject to the supermajority votes for some matters, all other elections and questions presented to the stockholders shall be decided by the affirmative vote of the holders of a majority in voting power of the votes cast affirmatively or negatively (excluding abstentions) at the meeting by the holders entitled to vote thereon. Our Certificate of Incorporation and Bylaws also provide that our board of directors or any individual director may be removed only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistent with, several of the provisions of our Certificate of Incorporation. See below under “Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws — Amendment of Charter Provisions.”
Holders of our Class B common stock have identical rights to holders of our Class A common stock as set forth in the preceding paragraph, other than as follows: (i) except as otherwise expressly provided in our Certificate of Incorporation or as required by applicable law, on any matter that is submitted to a vote by our stockholders, while holders of our Class A common stock are entitled to one vote per share of Class A common stock, holders of our Class B common stock are not entitled to any votes per share of Class B common stock, including for the election of directors, and (ii) while holders of our Class A common stock have no conversion rights, holders of our Class B common stock shall have the right to convert each share of our Class B common stock into one share of Class A common stock at such holder’s election, provided that as a result of such conversion, such holder and all other persons or entities whose beneficial ownership of Class A common stock would be aggregated with the shares of Class A common stock held by the holder for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the applicable rules and regulations thereunder, would not beneficially own in excess of 4.9% of any class of our securities registered under the Exchange Act. Accordingly, the holders of a majority of the outstanding shares of Class A common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they so choose, other than any directors that holders of any preferred stock we may issue may be entitled to elect.
Holders of our common stock are entitled to receive proportionately any dividends as may be declared by our board of directors, subject to any preferential dividend rights of any series of preferred stock that we may designate and issue in the future, and to the requirements of law.
In the event of our liquidation or dissolution, the holders of our common stock are entitled to receive proportionately our net assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of our common stock have no preemptive, subscription, redemption or conversion rights. Our outstanding shares of common stock are validly issued, fully paid and nonassessable. The rights, preferences and privileges of holders of
common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.
Preferred Stock
Under the terms of our Certificate of Incorporation, our board of directors is authorized to direct us to issue shares of preferred stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.
The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from seeking to acquire, a majority of our outstanding voting stock.
Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws
Some provisions of Delaware law, our Certificate of Incorporation and our Bylaws could make the following transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions which provide for payment of a premium over the market price for our shares.
Undesignated Preferred Stock
The ability of our board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with voting or other rights or preferences as designated by our board of directors could impede the success of any attempt to change control of us. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control or management of the Company.
Stockholder Meetings
Our Bylaws provide that a special meeting of stockholders may be called only by our board of directors, chairperson of the board, chief executive officer or president (in the absence of a chief executive officer).
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our Bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors.
Elimination of Stockholder Action by Written Consent
Our Certificate of Incorporation eliminates the right of stockholders to act by written consent without a meeting.
Staggered Board
In accordance with our Certificate of Incorporation, and subject to the rights of holders of any series of preferred stock to elect directors, our board of directors is divided into three classes. Each class shall consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire board of directors. The directors in each class will serve for a three-year term, with one class being elected each year by our stockholders. Our Certificate of Incorporation and Bylaws provide that the authorized number of directors may be changed only by resolution of the board of directors. This system of electing and removing directors may delay or prevent a change of management or a change in control of our company
and tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Removal of Directors
Our Certificate of Incorporation provides that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of the holders of at least two-thirds in voting power of the outstanding shares of stock entitled to vote in the election of directors.
Stockholders Not Entitled to Cumulative Voting
Our Certificate of Incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, a plurality of the votes cast by holders of shares of our Class A common stock shall be sufficient to elect all of the directors standing for election, if they choose, other than any directors that holders of our preferred stock may be entitled to elect.
Delaware Anti-Takeover Statute
We are subject to Section 203 of the DGCL, which prohibits persons deemed to be “interested stockholders” from engaging in a “business combination” with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.
Choice of Forum
Our Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative form, the Court of Chancery of the State of Delaware is the sole and exclusive forum for: (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, employees or stockholders; (3) any action asserting a claim against us arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware; or (4) any action asserting a claim governed by the internal affairs doctrine. Under our Certificate of Incorporation, this exclusive forum provision does not apply to suits brought to enforce any liability or duty created by the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. If and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Our Certificate of Incorporation further provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Our Certificate of Incorporation also provides that any person or entity purchasing or otherwise acquiring or holding any interest in shares of our capital stock shall be deemed to have notice of and to have consented to this choice of forum provision. It is possible that a court of law could rule that the choice of forum provision contained in our Certificate of Incorporation is inapplicable or unenforceable if it is challenged in a proceeding or otherwise.
Amendment of Charter Provisions
The amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue preferred stock and the provision prohibiting cumulative voting, would require approval by holders of at least two-thirds in voting power of the outstanding shares of stock entitled to vote thereon.
The provisions of Delaware law, our Certificate of Incorporation and our Bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our Class A common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of our board and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.
Stock Exchange Listing
Our Class A common stock is listed on The Nasdaq Capital Market under the symbol “ELUT.”
PLAN OF DISTRIBUTION
We entered into the Sales Agreement with the Agent on March 17, 2025. Pursuant to this prospectus, we may offer and sell shares of our Class A common stock having an aggregate gross sales price of up to $50.0 million from time to time through or to the Agent acting as sales agent or principal. A copy of the Sales Agreement has been filed as an exhibit to our registration statement on Form S-3 of which this prospectus forms a part.
Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Sales Agreement, the Agent may sell shares of our Class A common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may instruct the Agent not to sell Class A common stock if the sales cannot be effected at or above the price designated by us from time to time. We or the Agent may suspend the offering of Class A common stock upon notice and subject to other conditions.
We will pay the Agent’s commissions, in cash, for its services in acting as sales agent in the sale of our Class A common stock. The aggregate compensation payable to the Agent will be equal to 3.0% of the aggregate gross proceeds from each sale of shares of Class A common stock by the Agent pursuant to the Sales Agreement. We have also agreed to reimburse a portion of the Agent’s expenses, including the legal fees, in connection with this offering, and disbursements of its legal counsel, (a) in an amount not to exceed $75,000 in connection with the execution of the Sales Agreement, (b) in an amount not to exceed $25,000 per calendar quarter thereafter payable in connection with each representation date with respect to which we are obligated to deliver a certificate to the Agent pursuant to the Sales Agreement for which no waiver is applicable and excluding the date of the Sales Agreement, and (c) in an amount not to exceed $40,000 for each program “refresh” (filing of a new registration statement, prospectus or prospectus supplement relating to the shares of Class A common stock to be sold pursuant to the Sales Agreement and/or an amendment of the Sales Agreement) executed pursuant to the Sales Agreement. In accordance with FINRA Rule 5110 these reimbursed fees and expenses are deemed sales compensation in connection with this offering. We estimate that the total expenses for the offering, excluding compensation and reimbursements, if any, payable to the Agent under the terms of the Sales Agreement, will be approximately $500,000. Because there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time.
Settlement for sales of shares of Class A common stock will occur on the first trading day following the date on which any sales are made (or such earlier day as is industry practice for regular-way trading), or on some other date that is agreed upon by us and the Agent in connection with a particular transaction, in return for payment of the net proceeds to us. Sales of our Class A common stock as contemplated in this prospectus will be settled through the facilities of The Depository Trust Company or by such other means as we and the Agent may agree upon. There is no arrangement for funds to be received in an escrow, trust or similar arrangement.
The Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices, to solicit offers to purchase shares of our Class A common stock under the terms and subject to the conditions set forth in the Sales Agreement. In connection with the sale of the shares of Class A common stock on our behalf, the Agent will be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation of the Agent will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to the Agent against certain liabilities, including liabilities under the Securities Act and the Exchange Act.
The offering of shares of our Class A common stock pursuant to the Sales Agreement will terminate upon the earlier of (1) the sales of all shares of our Class A common stock subject to the Sales Agreement, or (2) the termination of the Sales Agreement as permitted therein. We and the Agent may each terminate the Sales Agreement at any time upon ten days’ prior notice.
The Agent and its affiliates may in the future provide various investment banking, commercial banking and other financial services for us, our subsidiaries and our affiliates, for which services they may in the future receive customary fees.
LEGAL MATTERS
The validity and enforceability, as applicable, of the Class A common stock being offered by this prospectus will be passed upon for us by Kilpatrick Townsend & Stockton LLP, Atlanta, Georgia. Duane Morris LLP, New York, New York, is representing Cantor Fitzgerald & Co. in connection with the offering.
EXPERTS
The financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December 31, 2024 have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as described in Note 2 to the financial statements) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
Available Information
We file reports, proxy statements and other information with the SEC. The SEC maintains a web site that contains reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.
Our web site address is www.elutia.com. The information on our web site, however, is not, and should not be deemed to be, a part of this prospectus.
This prospectus is part of a registration statement that we filed with the SEC and does not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us, as provided below. For further information with respect to us and the Class A common stock covered by this prospectus, please see the registration statement and the exhibits filed with the registration statement. Whenever we make reference in this prospectus to any of our contracts, agreements or other documents, the references are not necessarily complete and you should refer to the exhibits filed as part of the registration statement for copies of the actual contract, agreement or other document. You may inspect a copy of the registration statement through the SEC’s website, as provided above.
Incorporation by Reference
The SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information.
Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.
This prospectus incorporates by reference the documents set forth below (SEC File No. 001-39577) that have previously been filed with the SEC (other than those documents or the portions of those documents not deemed to be filed):
•
•
•
•
The description of our Class A common stock and Class B common stock contained in Exhibit 4.9 to our Annual Report on Form 10-K for the ended December 31, 2024, filed with the SEC on March 11, 2025, and any amendment or report filed with the SEC for the purpose of updating the description.
All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, which we refer to as the “Exchange Act” in this prospectus, prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports and documents.
You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:
Elutia Inc.
12510 Prosperity Drive, Suite 370 Silver Spring, MD 20904
(240) 247-1170
Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus.
ELUTIA INC.
Up to $50,000,000
Shares of Class A Common Stock
PROSPECTUS
Cantor
March , 2025
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following is an estimate of the expenses (all of which are to be paid by the registrant) that we may incur in connection with the securities being registered hereby. All such expenses are estimates, other than the registration fee payable to the Securities and Exchange Commission and fee payable to FINRA.
| |
SEC registration fee
|
|
|
|
$ |
14,292 |
|
|
| |
FINRA fee
|
|
|
|
$ |
13,744 |
|
|
| |
Printing expenses
|
|
|
|
|
(1)
|
|
|
| |
Legal fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Accounting fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
“Blue sky” fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Transfer agent fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Warrant agent fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Trustee fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Rating agency fees and expenses
|
|
|
|
|
(1)
|
|
|
| |
Miscellaneous
|
|
|
|
|
(1)
|
|
|
| |
Total
|
|
|
|
$ |
(1)
|
|
|
(1)
Fees and expenses will depend on the number and nature of the securities offered and cannot be estimated at this time. An estimate of the aggregate expenses in connection with the issuance and distribution of the securities offered will be included in any applicable prospectus supplement.
Item 15. Indemnification of Directors and Officers
Subsection (a) of Section 145 of the General Corporation Law of the State of Delaware, or the DGCL, empowers a corporation to indemnify any person who was or is a party or who is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the person’s conduct was unlawful.
Subsection (b) of Section 145 empowers a corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person acted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.
Section 145 further provides that to the extent a director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (a) and (a) of Section 145, or in defense of any claim, issue or matter therein, such person shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection therewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights to which the indemnified party may be entitled; and the indemnification provided for by Section 145 shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of such person’s heirs, executors and administrators. Section 145 also empowers the corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of his status as such, whether or not the corporation would have the power to indemnify such person against such liabilities under Section 145.
Section 102(b)(7) of the DGCL provides that a corporation’s certificate of incorporation may contain a provision eliminating or limiting the personal liability of a director to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, provided that such provision shall not eliminate or limit the liability of a director (i) for any breach of the director’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL, or (iv) for any transaction from which the director derived an improper personal benefit.
Any underwriting agreement or distribution agreement that the registrant enters into with any underwriters or agents involved in the offering or sale of any securities registered hereby may require such underwriters or dealers to indemnify the registrant, some or all of its directors and officers and its controlling persons, if any, for specified liabilities, which may include liabilities under the Securities Act of 1933, as amended.
Our bylaws provide that we will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding (other than an action by or in the right of us) by reason of the fact that he or she is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons being referred to as an “indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding and any appeal therefrom, if such indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable cause to believe his or her conduct was unlawful. Our bylaws provide that we will indemnify any indemnitee who was or is a party to an action or suit by or in the right of us to procure a judgment in our favor by reason of the fact that the Indemnitee is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding, and any appeal therefrom, if the indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, except that no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless a court determines that, despite such adjudication but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to the extent that any indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by us against all expenses (including attorneys’ fees) actually and reasonably incurred in connection therewith. Expenses must be advanced to an Indemnitee under certain circumstances.
We have entered into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for
some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.
We maintain a general liability insurance policy that covers certain liabilities of directors and officers of our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.
Item 16. Exhibits
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Exhibit
Number
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Description
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Form
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File No.
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Exhibit
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Filing Date
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1.1**
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Underwriting Agreement
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1.2*
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Controlled Equity OfferingSM Sales Agreement between Elutia Inc. and Cantor Fitzgerald & Co. dated March 17, 2025 |
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2.1
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8-K
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001-39577
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10.1
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9/19/2023
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3.1.a
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8-K
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001-39577
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3.1
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10/13/2020
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3.1.b
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8-K
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001-39577
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3.1
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09/07/2023
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3.2
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8-K
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001-39577
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3.2
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10/13/2020
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4.1
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S-1
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333-248788
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4.1
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09/14/2020
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4.2
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S-1
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333-248788
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4.2
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09/14/2020
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4.3
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S-1/A
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333-248788
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4.3
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09/30/2020
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4.4
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8-K
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001-39577
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4.1
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8/15/2022
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4.5
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8-K
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001-39577
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4.1
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9/21/2023
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4.6
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8-K
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001-39577
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4.2
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9/21/2023
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4.7
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8-K
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001-39577
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10.2
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9/21/2023
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4.8
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8-K
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001-39577
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4.1
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6/18/2024
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4.9
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10-K
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001-39577
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4.4
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03/15/2021
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4.10
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8-K
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001-39577
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4.1
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02/04/2025
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4.11
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Reference is made to Exhibits 3.1.a, 3.1.b and 3.2
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4.12
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S-3
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333-267197
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4.4
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08/31/2022
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4.13**
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Form of Specimen Certificate Representing Preferred Stock
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4.14**
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Form of Debt Security
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4.15**
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Form of Common Warrant
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4.16**
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Form of Prefunded Warrant
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4.17**
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Form of Warrant agreement
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4.18**
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Form of Unit Agreement
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Exhibit
Number
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Description
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Form
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File No.
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Exhibit
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Filing Date
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5.1*
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23.1*
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23.2*
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24.1*
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25.1***
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Statement of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of trustee under the indenture filed as Exhibit 4.12 above
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107*
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*
Filed herewith.
**
To be filed by amendment or incorporated by reference in connection with an offering of securities.
***
To be filed in accordance with the requirements of Section 305(b)(2) of the Trust Indenture Act of 1939.
Item 17. Undertakings
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
provided, however, that paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(5) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
(6) That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:
The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv) Any other communications that is an offer in the offering made by the undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(h) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Silver Spring, Maryland on March 14, 2025.
ELUTIA INC.
By:
/s/ C. Randal Mills, Ph.D.
C. Randal Mills, Ph.D.
President and Chief Executive Officer
POWER OF ATTORNEY
Each of the undersigned officers and directors of the registrant hereby severally constitutes and appoints C. Randal Mills, Ph.D. and Matthew Ferguson, or either of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, and in any and all capacities, to file and sign any and all amendments, including post-effective amendments, to this registration statement and any other registration statement for the same offering that is to be effective under Rule 462(b) of the Securities Act of 1933, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith and about the premises as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof. This power of attorney shall be governed by and construed with the laws of the State of Delaware and applicable federal securities laws.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.
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Name
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Title
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Date
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/s/ C. Randal Mills, Ph.D.
C. Randal Mills, PhD.
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President, Chief Executive Officer and Director (principal executive officer)
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March 14, 2025
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/s/ Matthew Ferguson
Matthew Ferguson
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Chief Financial Officer (principal financial officer and (principal accounting officer)
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March 15, 2025
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/s/ Kevin Rakin
Kevin Rakin
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Chairman of the Board of Directors
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March 15, 2025
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/s/ W. Matthew Zuga
W. Matthew Zuga
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Director
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March 15, 2025
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/s/ Maybelle Jordan
Maybelle Jordan
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Director
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March 15, 2025
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/s/ Brigid A. Makes
Brigid A. Makes
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Director
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March 14, 2025
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/s/ David Colpman
David Colpman
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Director
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March 17, 2025
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Exhibit 1.2
ELUTIA
INC.
Shares of Class A Common Stock
(par value $0.001 per share)
Controlled Equity OfferingSM
Sales Agreement
March 17, 2025
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
Ladies and Gentlemen:
Elutia Inc., a Delaware corporation
(the “Company”), confirms its agreement (this “Agreement”) with Cantor Fitzgerald &
Co. (the “Agent”), as follows:
1. Issuance
and Sale of Shares. The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the
conditions set forth herein, it may issue and sell to or through the Agent, as sales agent or principal, shares of Class A common
stock of the Company, par value $0.001 per share (the “Common Stock”, and the shares of Common Stock to be sold
by the Agent hereunder, the “Placement Shares”); provided, however, that in no event shall the
Company issue or sell through the Agent such number or dollar amount of Placement Shares that would (a) exceed the number or dollar
amount of shares of Common Stock registered on the effective Registration Statement (defined below) pursuant to which the offering is
being made, (b) exceed the number of authorized but unissued shares of Common Stock (less shares of Common Stock issuable upon exercise,
conversion or exchange of any outstanding securities of the Company or otherwise reserved from the Company’s authorized capital
stock), (c) exceed the number or dollar amount of shares of Common Stock permitted to be sold under Form S-3 (including General
Instruction I.B.6 thereof, if applicable) or (d) exceed the number or dollar amount of shares of Common Stock for which the Company
has filed a Sales Prospectus (defined below) (the lesser of (a), (b), (c) and (d), the “Maximum Amount”).
Notwithstanding anything to the contrary contained herein, the parties hereto agree that compliance with the limitations set forth in
this Section 1 on the amount of Placement Shares issued and sold under this Agreement shall be the sole responsibility of
the Company and that the Agent shall have no obligation in connection with such compliance. The offer and sale of Placement Shares through
the Agent will be effected pursuant to the Registration Statement (as defined below) filed by the Company and which will be declared effective
by the Securities and Exchange Commission (the “Commission”), although nothing in this Agreement shall be construed
as requiring the Company to use the Registration Statement to issue Common Stock.
The Company has filed or will
file, in accordance with the provisions of the Securities Act of 1933, as amended (the “Securities Act”), and
the rules and regulations thereunder (the “Securities Act Regulations”), with the Commission a registration
statement on Form S-3, including a base prospectus, relating to certain securities, including the Placement Shares to be issued from
time to time by the Company, and which incorporates by reference documents that the Company has filed or will file in accordance with
the provisions of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the rules and
regulations thereunder. The Company has prepared a prospectus or a prospectus supplement to the base prospectus included as part of the
registration statement, which prospectus or prospectus supplement relates to the Placement Shares to be issued from time to time by the
Company (whether a standalone prospectus or a combination of the base prospectus and a prospectus supplement related to the Placement
Shares, the “Sales Prospectus”). The Company will furnish to the Agent, for use by the Agent, copies of the
Sales Prospectus relating to the Placement Shares to be issued from time to time by the Company. Except where the context otherwise requires,
such registration statement(s), including all documents filed as part thereof or incorporated by reference therein, and including any
information contained in a Prospectus (as defined below) subsequently filed with the Commission pursuant to Rule 424(b) under
the Securities Act Regulations or deemed to be a part of such registration statement pursuant to Rule 430B of the Securities Act
Regulations, and any one or more additional effective registration statements on Form S-3 from time to time that will contain a base
prospectus and/or a prospectus or prospectus supplement related to the Placement Shares, if applicable (which shall be a Sales Prospectus)
is herein called the “Registration Statement.” The base prospectus or base prospectuses or Sales Prospectus,
including all documents incorporated therein by reference, included in the Registration Statement, as it may be supplemented, if necessary,
by a prospectus supplement, in the form in which such prospectus or prospectuses and/or prospectus supplement have most recently been
filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act Regulations, together with the then
issued Issuer Free Writing Prospectus(es) (as defined below), in each case related to the Placement Shares, is herein called the “Prospectus.”
Any reference herein to the
Registration Statement, the Sales Prospectus, the Prospectus or any Issuer Free Writing Prospectus shall be deemed to refer to and include
the documents, if any, incorporated by reference therein (the “Incorporated Documents”), including, unless the
context otherwise requires, the documents, if any, filed as exhibits to such Incorporated Documents. Any reference herein to the terms
“amend,” “amendment” or “supplement” with respect to the Registration Statement, the Sales Prospectus,
the Prospectus or any Issuer Free Writing Prospectus shall be deemed to refer to and include the filing of any document under the Exchange
Act on or after the most-recent effective date of the Registration Statement, or the date of the Sales Prospectus, Prospectus or such
Issuer Free Writing Prospectus, as the case may be, and incorporated therein by reference. For purposes of this Agreement, all references
to the Registration Statement, the Prospectus or to any amendment or supplement thereto shall be deemed to include the most recent copy
filed with the Commission pursuant to its Electronic Data Gathering Analysis and Retrieval system, or if applicable, the Interactive Data
Electronic Application system when used by the Commission (collectively, “EDGAR”).
2. Placements.
Each time that the Company wishes to issue and sell Placement Shares hereunder (each, a “Placement”), it will
notify the Agent by email notice (or other method mutually agreed to by the parties) of the number of Placement Shares to be issued,
the time period during which sales are requested to be made, any limitation on the number of Placement Shares that may be sold in any
one day and any minimum price below which sales may not be made (a “Placement Notice”), the form of which is
attached hereto as Schedule 1. The Placement Notice shall originate from any of the individuals from the Company set forth on
Schedule 3 (with a copy to each of the other individuals from the Company listed on such schedule), and shall be addressed to
each of the individuals from the Agent set forth on Schedule 3, as such Schedule 3 may be amended from time to time. The
Placement Notice shall be effective unless and until (i) the Agent declines in writing (which may be by email) to accept the terms
contained therein for any reason, in its sole discretion, (ii) the entire amount of the Placement Shares thereunder have been sold,
(iii) the Company amends, supersedes, suspends or terminates the Placement Notice or (iv) this Agreement has been terminated
under the provisions of Section 12. The amount of any discount, commission or other compensation to be paid by the Company
to the Agent in connection with the sale of the Placement Shares shall be calculated in accordance with the terms set forth in Schedule
2. It is expressly acknowledged and agreed that neither the Company nor the Agent will have any obligation whatsoever with respect
to a Placement or any Placement Shares unless and until the Company delivers a Placement Notice to the Agent and the Agent does not timely
decline such Placement Notice pursuant to the terms set forth above, and then only upon the terms specified therein and herein. In the
event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the Placement Notice will control.
3. Sale
of Placement Shares by the Agent. Subject to the provisions of Section 5(a), the Agent, for the period specified in the
Placement Notice, will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state
and federal laws, rules and regulations and the rules of the Nasdaq Capital Market (the “Exchange”),
to sell the Placement Shares up to the amount specified in, and otherwise in accordance with the terms of, such Placement Notice. The
Agent will provide written confirmation to the Company no later than the opening of the Trading Day (as defined below) immediately following
the Trading Day on which it has made sales of Placement Shares hereunder setting forth the number of Placement Shares sold on such day,
the compensation payable by the Company to the Agent pursuant to Section 2 with respect to such sales, and the Net Proceeds
(as defined below) payable to the Company, with an itemization of the deductions made by the Agent (as set forth in Section 5(b))
from the gross proceeds that it receives from such sales. Subject to the terms of the Placement Notice, the Agent may sell Placement Shares
by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities
Act Regulations. “Trading Day” means any day on which Common Stock is traded on the Exchange.
4. Suspension
of Sales. The Company or the Agent may, upon notice to the other party in writing (including by email correspondence to each of the
individuals of the other party set forth on Schedule 3, if receipt of such correspondence is actually acknowledged by any of the
individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by verifiable facsimile transmission
or email correspondence to each of the individuals of the other party set forth on Schedule 3), suspend any sale of Placement Shares
(a “Suspension”); provided, however, that such Suspension shall not affect or impair any party’s
obligations with respect to any Placement Shares sold hereunder prior to the receipt of such notice. While a Suspension is in effect any
obligation under Sections 7(l), 7(m), and 7(n) with respect to the delivery of certificates, opinions, or comfort
letters to the Agent, shall be waived. Each of the parties agrees that no such notice under this Section 4 shall be effective
against any other party unless it is made to one of the individuals named on Schedule 3 hereto, as such Schedule may be amended
from time to time. Notwithstanding any other provision of this Agreement, during any period in which the Company is in possession of material
non-public information, the Company and the Agent agree that (i) no sale of Placement Shares will take place, (ii) the Company
shall not request the sale of any Placement Shares, and (iii) the Agent shall not be obligated to sell or offer to sell any Placement
Shares.
5. Sale
and Delivery to the Agent; Settlement.
(a) Sale
of Placement Shares. On the basis of the representations and warranties herein contained and subject to the terms and conditions
herein set forth, upon the Agent’s acceptance of the terms of a Placement Notice, and unless the sale of the Placement Shares described
therein has been declined, amended, superseded, suspended, or otherwise terminated in accordance with the terms of this Agreement, the
Agent, for the period specified in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading
and sales practices and applicable law and regulations to sell such Placement Shares up to the amount specified, and otherwise in accordance
with the terms of such Placement Notice. The Company acknowledges and agrees that (i) there can be no assurance that the Agent will
be successful in selling Placement Shares, (ii) the Agent will incur no liability or obligation to the Company or any other person
or entity if it does not sell Placement Shares for any reason other than a failure by the Agent to use its commercially reasonable efforts
consistent with its normal trading and sales practices and applicable law and regulations to sell such Placement Shares as required under
this Agreement and (iii) the Agent shall be under no obligation to purchase Placement Shares on a principal basis pursuant to this
Agreement, except as otherwise agreed by the Agent and the Company.
(b) Settlement
of Placement Shares. Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares
will occur on the first (1st) Trading Day (or such earlier day as is industry practice for regular-way trading) following the date on
which such sales are made (each, a “Settlement Date”). The Agent shall notify the Company of each sale of Placement
Shares no later than the opening of the Trading Day immediately following the Trading Day on which it has made sales of Placement Shares
hereunder. The amount of proceeds to be delivered to the Company on a Settlement Date against receipt of the Placement Shares sold (the
“Net Proceeds”) will be equal to the aggregate sales price received by the Agent, after deduction for (i) the
Agent’s commission, discount or other compensation for such sales payable by the Company pursuant to Section 2 hereof,
and (ii) any transaction fees imposed by any Governmental Authority in respect of such sales.
(c) Delivery
of Placement Shares. On or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically transfer
the Placement Shares being sold by crediting the Agent’s or its designee’s account (provided the Agent shall have given the
Company written notice of such designee at least one Trading Day prior to the Settlement Date) at The Depository Trust Company through
its Deposit and Withdrawal at Custodian System (“DWAC”) or by such other means of delivery as may be mutually
agreed upon by the parties hereto which in all cases shall be freely tradable, transferable, registered shares in good deliverable form.
On each Settlement Date, the Agent will deliver the related Net Proceeds in same day funds to an account designated by the Company on,
or prior to, the Settlement Date. The Agent will provide DWAC instructions or instructions for delivery by other means with regard to
the deliver of the Placement Shares to the Company and its transfer agent. The Company agrees that if the Company, or its transfer agent
(if applicable), defaults in its obligation to deliver Placement Shares on a Settlement Date (other than due to the failure of the Agent
to provide correct delivery instructions as provided in the preceding sentence), then in addition to and in no way limiting the rights
and obligations set forth in Section 10(a) hereto, it will (i) hold the Agent harmless against any loss, claim,
damage, or reasonable expense (including reasonable legal fees and expenses), as incurred, arising out of or in connection with such default
by the Company or its transfer agent (if applicable) and (ii) pay to the Agent (without duplication) any commission, discount, or
other compensation to which it would otherwise have been entitled absent such default.
(d) Denominations;
Registration. Any Placement Shares that are sold shall not be represented by physical certificates without the prior written
consent of the Company. Certificates for the Placement Shares, if any, shall be in such denominations and registered in such names as
the Agent may request in writing at least one full Business Day (as defined below) before the applicable Settlement Date. The certificates
for the Placement Shares, if any, will be made available by the Company for examination and packaging by the Agent in The City of New
York not later than noon (New York time) on the Business Day prior to the applicable Settlement Date.
(e) Limitations
on Offering Size. Under no circumstances shall the Company cause or request the offer or sale of any Placement Shares if, after
giving effect to the sale of such Placement Shares, the aggregate gross sales proceeds of Placement Shares sold pursuant to this Agreement
would exceed the lesser of (A) together with all sales of Placement Shares under this Agreement, the Maximum Amount and (B) the
amount authorized from time to time to be issued and sold under this Agreement by the Company’s board of directors, a duly authorized
committee thereof or a duly authorized delegate, and notified to the Agent in writing. Under no circumstances shall the Company cause
or request the offer or sale of any Placement Shares pursuant to this Agreement at a price lower than the minimum price authorized from
time to time by the Company’s board of directors, a duly authorized committee thereof or a duly authorized delegate. Further, under
no circumstances shall the Company cause or permit the aggregate offering amount of Placement Shares sold pursuant to this Agreement to
exceed the Maximum Amount.
6. Representations
and Warranties of the Company. The Company represents and warrants to, and agrees with the Agent that as of the date of this Agreement
and as of each Applicable Time (as defined below) unless such representation, warranty or agreement specifies a different time:
(a) Registration
Statement and Prospectus. The Company and the transactions contemplated by this Agreement meet the requirements for and comply with
the applicable conditions set forth in Form S-3 (including General Instructions I.A and I.B) under the Securities Act. The Registration
Statement has been or will be filed with the Commission and will be declared effective by the Commission under the Securities Act prior
to the issuance of any Placement Notices by the Company. As of each Applicable Time, the Registration Statement is effective. The Sales
Prospectus will name the Agent as the agent in the section entitled “Plan of Distribution.” The Company has not received,
and has no notice of, any order of the Commission preventing or suspending the use of the Registration Statement, or threatening or instituting
proceedings for that purpose. The Registration Statement and the offer and sale of Placement Shares as contemplated hereby meet the requirements
of Rule 415 under the Securities Act and comply in all material respects with said Rule. Any statutes, regulations, contracts or
other documents that are required to be described in the Registration Statement or the Prospectus or to be filed as exhibits to the Registration
Statement have been so described or filed. Copies of the Registration Statement, the Prospectus, and any such amendments or supplements
and all documents incorporated by reference therein that were filed with the Commission on or prior to the date of this Agreement have
been delivered, or are available through EDGAR, to the Agent and its counsel. The Company has not distributed and, prior to the later
to occur of each Settlement Date and completion of the distribution of the Placement Shares, will not distribute any offering material
in connection with the offering or sale of the Placement Shares other than the Registration Statement and the Prospectus and any Issuer
Free Writing Prospectus to which the Agent has consented (not to be unreasonably withheld). The Common Stock is registered pursuant to
Section 12(b) of the Exchange Act and is currently listed on the Exchange under the trading symbol “ELUT.” The Company
has taken no action designed to, or likely to have the effect of, terminating the registration of the Common Stock under the Exchange
Act, delisting the Common Stock from the Exchange, nor has the Company received any notification that the Commission or the Exchange is
contemplating terminating such registration or listing. To the Company’s knowledge, it is in compliance with all applicable listing
requirements of the Exchange.
(b) No
Misstatement or Omission. The Registration Statement, when it became or becomes effective, and the Prospectus, and any amendment or
supplement thereto, on the date of such Prospectus or amendment or supplement, conformed and will conform in all material respects with
the requirements of the Securities Act. At each Settlement Date, the Registration Statement and the Prospectus, as of such date, will
conform in all material respects with the requirements of the Securities Act. The Registration Statement, when it became or becomes effective,
did not, and will not, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or
necessary to make the statements therein not misleading. The Prospectus and any amendment and supplement thereto, on the date thereof
and at each Applicable Time (defined below), did not or will not include an untrue statement of a material fact or omit to state a material
fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The documents
incorporated by reference in the Prospectus or any Sales Prospectus did not, and any further documents filed and incorporated by reference
therein will not, when filed with the Commission, contain an untrue statement of a material fact or omit to state a material fact required
to be stated in such document or necessary to make the statements in such document, in light of the circumstances under which they were
made, not misleading. The foregoing shall not apply to statements in, or omissions from, any such document made in reliance upon, and
in conformity with, information furnished to the Company by the Agent in writing specifically for use in the preparation thereof, it being
understood and agreed that the only such information furnished by the Agent to the Company consists of “Agent Information”
as defined below.
(c) Conformity
with the Securities Act and Exchange Act. The Registration Statement, the Prospectus, any Issuer Free Writing Prospectus or any amendment
or supplement thereto, and the documents incorporated by reference in the Registration Statement, the Prospectus or any amendment or supplement
thereto, when such documents were or are filed with the Commission under the Securities Act or the Exchange Act or became or become effective
under the Securities Act, as the case may be, conformed or will conform in all material respects with the requirements of the Securities
Act and the Exchange Act, as applicable.
(d) Financial
Information. The consolidated financial statements of the Company included or incorporated by reference in the Registration Statement,
the Prospectus and the Issuer Free Writing Prospectuses, if any, together with the related notes and schedules, present fairly, in all
material respects, the consolidated financial position of the Company and the Subsidiaries (as defined below) as of the dates indicated
and the consolidated results of operations, cash flows and changes in stockholders’ equity of the Company for the periods specified
and have been prepared in compliance with the requirements of the Securities Act and Exchange Act and in conformity with U.S. Generally
Accepted Accounting Principles (“GAAP”) applied on a consistent basis during the periods involved (except (i) as
may be otherwise indicated in such financial statements or notes thereto, or (ii) in the case of unaudited financial statements,
to the extent they may exclude footnotes or may be condensed or summary statements and subject to normal year-end audit adjustments);
the other financial and statistical data with respect to the Company and the Subsidiaries (as defined below) contained or incorporated
by reference in the Registration Statement, the Prospectus and the Issuer Free Writing Prospectuses, if any, are accurately and fairly
presented in all material respects and prepared on a basis consistent with the financial statements and books and records of the Company;
there are no financial statements (historical or pro forma) that are required to be included or incorporated by reference in the Registration
Statement, or the Prospectus that are not included or incorporated by reference as required; the Company and the Subsidiaries (as defined
below) do not have any material liabilities or obligations, direct or contingent (including any off-balance sheet obligations), not described
in the Registration Statement (excluding the exhibits thereto), and the Prospectus; and all disclosures contained or incorporated by reference
in the Registration Statement, the Prospectus and the Issuer Free Writing Prospectuses, if any, regarding “non-GAAP financial measures”
(as such term is defined by the rules and regulations of the Commission) comply with Regulation G of the Exchange Act and Item 10
of Regulation S-K under the Securities Act, to the extent applicable. The interactive data in eXtensible Business Reporting Language included
or incorporated by reference in the Registration Statement and the Prospectus fairly presents the information called for in all material
respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto.
(e) Conformity
with EDGAR Filing. The Prospectus delivered to the Agent for use in connection with the sale of the Placement Shares pursuant to this
Agreement will be identical to the versions of the Prospectus created to be transmitted to the Commission for filing via EDGAR, except
to the extent permitted by Regulation S-T.
(f) Organization.
The Company and each of its Subsidiaries are duly organized, validly existing as a corporation or limited liability company and in good
standing under the laws of their respective jurisdictions of organization. The Company and each of its Subsidiaries are duly licensed
or qualified as a foreign corporation or limited liability company for transaction of business and in good standing under the laws of
each other jurisdiction in which their respective ownership or lease of property or the conduct of their respective businesses requires
such license or qualification, and have all corporate power and authority necessary to own or hold their respective properties and to
conduct their respective businesses as described in the Registration Statement and the Prospectus, except where the failure to be so qualified
or in good standing or have such power or authority would not, individually or in the aggregate, have a material adverse effect or would
reasonably be expected to have a material adverse effect on or affecting the assets, business, operations, earnings, properties, condition
(financial or otherwise), prospects, stockholders’ equity or results of operations of the Company and the Subsidiaries taken as
a whole, or prevent or materially interfere with consummation of the transactions contemplated hereby (a “Material Adverse
Effect”).
(g) Subsidiaries.
The subsidiaries set forth on Schedule 4 (collectively, the “Subsidiaries”), are the Company’s
only significant subsidiaries (as such term is defined in Rule 1-02 of Regulation S-X promulgated by the Commission). Except as set
forth in the Registration Statement and in the Prospectus, the Company owns, directly or indirectly, all of the equity interests of the
Subsidiaries free and clear of any lien, charge, security interest, encumbrance, right of first refusal or other restriction, and all
the equity interests of the Subsidiaries are validly issued and are fully paid, nonassessable and free of preemptive and similar rights.
No Subsidiary is currently prohibited, directly or indirectly, from paying any dividends to the Company, from making any other distribution
on such Subsidiary’s capital stock, from repaying to the Company any loans or advances to such Subsidiary from the Company or from
transferring any of such Subsidiary’s property or assets to the Company or any other Subsidiary of the Company.
(h) No
Violation or Default. Neither the Company nor any of its Subsidiaries is (i) in violation of its charter or by-laws or similar
organizational documents; (ii) in default, and no event has occurred that, with notice or lapse of time or both, would constitute
such a default, in the due performance or observance of any term, covenant or condition contained in any indenture, mortgage, deed of
trust, loan agreement or other agreement or instrument to which the Company or any of its Subsidiaries is a party or by which the Company
or any of its Subsidiaries is bound or to which any of the property or assets of the Company or any of its Subsidiaries are subject; or
(iii) in violation of any law or statute or any judgment, order, rule or regulation of any Governmental Authority, except, in
the case of each of clauses (ii) and (iii) above, for any such violation or default that would not, individually or in the aggregate,
have a Material Adverse Effect. To the Company’s knowledge, no other party under any material contract or other agreement to which
it or any of its Subsidiaries is a party is in default in any respect thereunder where such default would reasonably be expected to have
a Material Adverse Effect.
(i) No
Material Adverse Change. Subsequent to the respective dates as of which information is given in the Registration Statement, the Prospectus
and the Free Writing Prospectuses, if any (including any document deemed incorporated by reference therein) and other than the Company’s
execution of this Agreement, there has not been (i) any Material Adverse Effect or the occurrence of any development that the Company
reasonably expects will result in a Material Adverse Effect, (ii) any transaction which is material to the Company and the Subsidiaries
taken as a whole, (iii) any obligation or liability, direct or contingent (including any off-balance sheet obligations), incurred
by the Company or any Subsidiary, which is material to the Company and the Subsidiaries taken as a whole, (iv) any material change
in the capital stock or outstanding long-term indebtedness of the Company or any of its Subsidiaries or (v) any dividend or distribution
of any kind declared, paid or made on the capital stock of the Company or any Subsidiary, other than in each case above in the ordinary
course of business or as otherwise disclosed in the Registration Statement or Prospectus (including any document deemed incorporated by
reference therein).
(j) Capitalization.
The issued and outstanding shares of capital stock of the Company have been validly issued, are fully paid and nonassessable and, other
than as disclosed in the Registration Statement or the Prospectus, are not subject to any preemptive rights, rights of first refusal or
similar rights. The Company has an authorized, issued and outstanding capitalization as set forth in the Registration Statement and the
Prospectus as of the dates referred to therein (other than the grant of additional options under the Company’s existing stock option
plans, or changes in the number of outstanding shares of Common Stock of the Company due to the issuance of shares upon the exercise or
conversion of securities exercisable for, or convertible into, Common Stock outstanding on the date hereof) and such authorized capital
stock conforms in all material respects to the description thereof set forth in the Registration Statement and the Prospectus. Except
as disclosed in or contemplated by the Registration Statement or the Prospectus, as of the date referred to therein, the Company does
not have outstanding any options to purchase, or any rights or warrants to subscribe for, or any securities or obligations convertible
into, or exchangeable for, or any contracts or commitments to issue or sell, any shares of capital stock or other securities.
(k) Authorization;
Enforceability. The Company has full legal right, power and authority to enter into this Agreement and perform its obligations hereunder.
This Agreement has been duly authorized, executed and delivered by the Company and is a legal, valid and binding agreement of the Company
enforceable in accordance with its terms, except to the extent that (i) enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting creditors’ rights generally and by general equitable principles and (ii) the
indemnification and contribution provisions of Section 10 hereof may be limited by federal or state securities laws and public policy
considerations in respect thereof.
(l) Authorization
of Placement Shares. The Placement Shares, when issued and delivered pursuant to the terms approved by the board of directors of the
Company or a duly authorized committee thereof, or a duly authorized delegate, against payment therefor as provided herein, will be duly
and validly authorized and issued and fully paid and nonassessable, free and clear of any pledge, lien, encumbrance, security interest
or other claim, including any statutory or contractual preemptive rights, resale rights, rights of first refusal or other similar rights,
and will be registered pursuant to Section 12 of the Exchange Act. The Placement Shares, when issued, will conform in all material
respects to the description thereof set forth in or incorporated into the Prospectus.
(m) No
Consents Required. No consent, approval, authorization, order, registration or qualification of or with any Governmental Authority
is required for the execution, delivery and performance by the Company of this Agreement, the issuance and sale by the Company of the
Placement Shares, except for the filing of and declaration of the effectiveness of the Registration Statement by the Commission, such
consents, approvals, authorizations, orders and registrations or qualifications as may be required under applicable state securities laws
or by the by-laws and rules of the Financial Industry Regulatory Authority (“FINRA”) or the Exchange in
connection with the sale of the Placement Shares by the Agent.
(n) No
Preferential Rights. Except as set forth in the Registration Statement and the Prospectus, (i) no person, as such term is defined
in Rule 1-02 of Regulation S-X promulgated under the Securities Act (each, a “Person”), has the right,
contractual or otherwise, to cause the Company to issue or sell to such Person any Common Stock or shares of any other capital stock or
other securities of the Company, (ii) no Person has any preemptive rights, resale rights, rights of first refusal, rights of co-sale,
or any other rights (whether pursuant to a “poison pill” provision or otherwise) to purchase any Common Stock or shares of
any other capital stock or other securities of the Company, (iii) no Person has the right to act as an underwriter or as a financial
advisor to the Company in connection with the offer and sale of the Common Stock, and (iv) no Person has the right, contractual or
otherwise, to require the Company to register under the Securities Act any Common Stock or shares of any other capital stock or other
securities of the Company, or to include any such shares or other securities in the Registration Statement or the offering contemplated
thereby, whether as a result of the filing or effectiveness of the Registration Statement or the sale of the Placement Shares as contemplated
thereby or otherwise.
(o) Independent
Public Accounting Firm. PricewaterhouseCoopers LLP (the “Accountant”), whose report on the consolidated
financial statements of the Company is filed with the Commission as part of the Company’s most recent Annual Report on Form 10-K
filed with the Commission and incorporated by reference into the Registration Statement and the Prospectus, are and, during the periods
covered by their report, were an independent registered public accounting firm within the meaning of the Securities Act and the Public
Company Accounting Oversight Board (United States). To the Company’s knowledge, the Accountant is not in violation of the auditor
independence requirements of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) with respect to the Company.
(p) Enforceability
of Agreements. All agreements between the Company and third parties expressly referenced in the Prospectus are legal, valid and binding
obligations of the Company enforceable in accordance with their respective terms, except to the extent that (i) enforceability may
be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally and by general
equitable principles; (ii) the indemnification provisions of certain agreements may be limited by federal or state securities laws
or public policy considerations in respect thereof; or (iii) the unenforceability of any such agreements or provisions thereof would
not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(q) No
Litigation. Except as set forth in the Registration Statement or the Prospectus, there are no actions, suits or proceedings by or
before any Governmental Authority pending, nor, to the Company’s knowledge, any audits or investigations by or before any Governmental
Authority to which the Company or a Subsidiary is a party or to which any property of the Company or any of its Subsidiaries is the subject
that, individually or in the aggregate, would, if determined adversely to the Company or a Subsidiary, would reasonably be expected to
have a Material Adverse Effect and, to the Company’s knowledge, no such actions, suits, proceedings, audits or investigations are
threatened or contemplated by any Governmental Authority or threatened by others; and there are no current or pending audits or investigations,
actions, suits or proceedings by or before any Governmental Authority that are required under the Securities Act to be described in the
Prospectus that are not so described.
(r) Consents
and Permits. Except as disclosed in the Registration Statement and the Prospectus, the Company and its Subsidiaries have made all
filings, applications and submissions required by, possesses and is operating in compliance with, all approvals, licenses, certificates,
certifications, clearances, consents, grants, exemptions, marks, notifications, orders, permits and other authorizations issued by, the
appropriate federal, state or foreign Governmental Authority (including, without limitation, the United States Food and Drug Administration
(the “FDA”), the United States Drug Enforcement Administration or any other foreign, federal, state, provincial,
court or local government or regulatory authorities including self-regulatory organizations engaged in the regulation of clinical trials,
pharmaceuticals, biologics or biohazardous substances or materials) necessary for the ownership or lease of their respective properties
or to conduct its businesses as described in the Registration Statement and the Prospectus (collectively, “Permits”),
except for such Permits the failure of which to possess, obtain or make the same would not reasonably be expected to have a Material Adverse
Effect; the Company and its Subsidiaries are in compliance with the terms and conditions of all such Permits, except where the failure
to be in compliance would not have a Material Adverse Effect; all of the Permits are valid and in full force and effect, except where
any invalidity, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect; and neither the
Company nor any of its Subsidiaries has received any written notice relating to the limitation, revocation, cancellation, suspension,
modification or non-renewal of any such Permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or
finding, would have a Material Adverse Effect, or has any reason to believe that any such license, certificate, permit or authorization
will not be renewed in the ordinary course. To the extent required by applicable laws and regulations of the FDA, the Company or the applicable
Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial
it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and
rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.
(s) Regulatory
Filings. Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has
failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial
or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing,
registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse
Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations,
reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory
authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies
that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material
respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the
FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of
any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect
the results of the studies, tests and trials described in the Prospectus.
(t) Intellectual
Property. Except as disclosed in the Registration Statement and the Prospectus, the Company and its Subsidiaries own, possess, license
or have other rights to use all foreign and domestic patents, patent applications, trade and service marks, trade and service mark registrations,
trade names, copyrights, licenses, inventions, trade secrets, technology, Internet domain names, know-how and other intellectual
property (collectively, the “Intellectual Property”), necessary for the conduct of their respective businesses
as now conducted except to the extent that the failure to own, possess, license or otherwise hold adequate rights to use such Intellectual
Property would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in
the Registration Statement and the Prospectus (i) except pursuant to licenses or similar contractual rights granted by the Company
or its Subsidiaries which have been disclosed in the Registration Statement and the Prospectus, there are no rights of third parties to
any such Intellectual Property owned by the Company and its Subsidiaries; (ii) to the Company’s knowledge, there is no infringement
by third parties of any such Intellectual Property; (iii) there is no pending or, to the Company’s knowledge, threatened action,
suit, proceeding or claim by others challenging the Company’s and its Subsidiaries’ rights in or to any such Intellectual
Property, and the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim;
(iv) there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others challenging
the validity or scope of any such Intellectual Property; (v) there is no pending or, to the Company’s knowledge, threatened
action, suit, proceeding or claim by others that the Company and its Subsidiaries infringe or otherwise violate any patent, trademark,
copyright, trade secret or other proprietary rights of others; (vi) to the Company’s knowledge, there is no third-party U.S.
patent or published U.S. patent application which contains claims for which an Interference Proceeding (as defined in 35 U.S.C. §
135) has been commenced against any patent or patent application described in the Prospectus as being owned by or licensed to the Company;
and (vii) the Company and its Subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property
has been licensed to the Company or such Subsidiary, and all such agreements are in full force and effect, except, in the case of any
of clauses (i)-(vii) above, for any such third party rights, infringement by third parties, pending or threatened suit, action, proceeding
or claim, patent or patent application, contractual noncompliance or ineffectiveness as would not, individually or in the aggregate, reasonably
be expected to result in a Material Adverse Effect.
(u) Clinical
Studies. The preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being
conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where applicable,
accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company;
the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in
all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which
reasonably call into question the results of the tests, studies and trials described in the Prospectus in any material respect; and the
Company has not been the target of any written notice or correspondence from the FDA or any foreign, state or local Governmental Authority
exercising comparable authority or any institutional review board or comparable authority requiring the termination, suspension, clinical
hold or material modification of any tests, studies or trials with respect to products it still owns or markets.
(v) Market
Capitalization. At the time the Registration Statement was or will be originally declared effective, and at the time the Company’s
most recent Annual Report on Form 10-K was filed with the Commission, the Company met or will meet the then applicable requirements
for the use of Form S-3 under the Securities Act, including, but not limited to, General Instruction I.B.1 of Form S-3. The
Company is not a shell company (as defined in Rule 405 under the Securities Act) and has not been a shell company for at least 12
calendar months previously and if it has been a shell company at any time previously, has filed current Form 10 information (as defined
in Instruction I.B.6 of Form S-3) with the Commission at least 12 calendar months previously reflecting its status as an entity that
is not a shell company.
(w) FINRA
Matters. The information provided to the Agent by the Company, its counsel, and its officers and directors for purposes of the Agent’s
compliance with applicable FINRA rules in connection with the offering of the Shares is true, complete, and correct and compliant
with FINRA’s rules.
(x) No
Material Defaults. Neither the Company nor any of the Subsidiaries has defaulted on any installment on indebtedness for borrowed money
or on any rental on one or more long-term leases, which defaults, individually or in the aggregate, would reasonably be expected to have
a Material Adverse Effect. The Company has not filed a report pursuant to Section 13(a) or 15(d) of the Exchange Act since
the filing of its last Annual Report on Form 10-K, indicating that it (i) has failed to pay any dividend or sinking fund installment
on preferred stock or (ii) has defaulted on any installment on indebtedness for borrowed money or on any rental on one or more long-term
leases, which defaults, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.
(y) Certain
Market Activities. Neither the Company, nor any of the Subsidiaries, nor, to the Company’s knowledge, any of their respective
directors, officers or controlling persons has taken, directly or indirectly, any action designed, or that has constituted or would reasonably
be expected to cause or result in, under the Exchange Act or otherwise, the stabilization or manipulation of the price of any security
of the Company to facilitate the sale or resale of the Placement Shares.
(z) Broker/Dealer
Relationships. Neither the Company nor any of the Subsidiaries (i) is required to register as a “broker” or “dealer”
in accordance with the provisions of the Exchange Act or (ii) directly or indirectly through one or more intermediaries, controls
or is a “person associated with a member” or “associated person of a member” (within the meaning set forth in
the FINRA Manual).
(aa) No
Reliance. The Company has not relied upon the Agent or legal counsel for the Agent for any legal, tax or accounting advice in connection
with the offering and sale of the Placement Shares.
(bb) Taxes.
The Company and each of its Subsidiaries have filed all federal, state, local and foreign tax returns which have been required to be filed
and paid all taxes shown thereon through the date hereof, to the extent that such taxes have become due and are not being contested in
good faith, except where the failure to so file or pay would not reasonably be expected to have a Material Adverse Effect. Except as otherwise
disclosed in or contemplated by the Registration Statement or the Prospectus, no tax deficiency has been determined adversely to the Company
or any of its Subsidiaries which has had, or would reasonably be expected to have, individually or in the aggregate, a Material Adverse
Effect. The Company has no knowledge of any federal, state or other governmental tax deficiency, penalty or assessment which has been
or might be asserted or threatened against it which would reasonably be expected to have a Material Adverse Effect.
(cc) Title
to Real and Personal Property. Except as set forth in the Registration Statement or the Prospectus, the Company and its Subsidiaries
have good and marketable title in fee simple or a valid leasehold interest to all items of real property owned by them, good and valid
title to all personal property described in the Registration Statement or Prospectus as being owned by them, in each case free and clear
of all liens, encumbrances and claims, except those matters that (i) do not materially interfere with the use made and proposed to
be made of such property by the Company and any of its Subsidiaries or (ii) would not, individually or in the aggregate, be reasonably
expected to have a Material Adverse Effect. Any real or personal property described in the Registration Statement or Prospectus as being
leased by the Company and any of its Subsidiaries is held by them under valid, existing and enforceable leases, except those that (A) do
not materially interfere with the use made or proposed to be made of such property by the Company or any of its Subsidiaries or (B) would
not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect. Each of the properties owned by the Company
and its Subsidiaries, if any, complies with all applicable codes, laws and regulations (including, without limitation, building and zoning
codes, laws and regulations and laws relating to access to such properties), except if and to the extent disclosed in the Registration
Statement or Prospectus or except for such failures to comply that would not, individually or in the aggregate, reasonably be expected
to interfere in any material respect with the use made and proposed to be made of such property by the Company and its Subsidiaries or
otherwise have a Material Adverse Effect. None of the Company or its Subsidiaries has received from any Governmental Authorities any notice
of any condemnation of, or zoning change affecting, the properties owned by the Company and its Subsidiaries, and the Company knows of
no such condemnation or zoning change which is threatened, except for such that would not reasonably be expected to interfere in any material
respect with the use made and proposed to be made of such property by the Company and its Subsidiaries or otherwise have a Material Adverse
Effect, individually or in the aggregate.
(dd) Environmental
Laws. Except as set forth in the Registration Statement or the Prospectus, the Company and its Subsidiaries (i) are in compliance
with any and all applicable federal, state, local and foreign laws, rules, regulations, decisions and orders relating to the protection
of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental
Laws”); (ii) have received and are in compliance with all permits, licenses or other approvals required of them under
applicable Environmental Laws to conduct their respective businesses as described in the Registration Statement and the Prospectus; and
(iii) have not received notice of any actual or potential liability for the investigation or remediation of any disposal or release
of hazardous or toxic substances or wastes, pollutants or contaminants, except, in the case of any of clauses (i), (ii) or (iii) above,
for any such failure to comply or failure to receive required permits, licenses, other approvals or liability as would not, individually
or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(ee) Disclosure
Controls. The Company and each of its Subsidiaries maintain systems of internal accounting controls designed to provide reasonable
assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions
are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability;
(iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the
recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect
to any differences. The Company’s internal control over financial reporting is effective and the Company is not aware of any material
weaknesses in its internal control over financial reporting (other than as set forth in the Prospectus). Since the date of the latest
audited financial statements of the Company included in the Prospectus, there has been no change in the Company’s internal control
over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control
over financial reporting (other than as set forth in the Prospectus). The Company has established disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15 and 15d-15) for the Company and designed such disclosure controls and procedures to ensure that
material information relating to the Company and each of its Subsidiaries is made known to the certifying officers by others within those
entities. The Company’s certifying officers have evaluated the effectiveness of the Company’s disclosure controls and procedures
as of a date within 90 days prior to the filing date of the Form 10-K for the fiscal year most recently ended (such date, the “Evaluation
Date”). The Company presented in its Form 10-K for the fiscal year most recently ended the conclusions of the certifying
officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date and the
disclosure controls and procedures are effective to provide reasonable assurance that the objectives of disclosure controls and procedures
are met. Since the Evaluation Date, except as may be set forth in the Prospectus, there have been no significant changes in the Company’s
internal controls (as such term is defined in Rule 13a-15(f) under the Exchange Act) or, to the Company’s knowledge, in
other factors that could significantly affect the Company’s internal controls.
(ff) Sarbanes-Oxley.
There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as
such, to comply in all material respects with any applicable provisions of the Sarbanes-Oxley Act and the rules and regulations promulgated
thereunder. Each of the principal executive officer and the principal financial officer of the Company (or each former principal executive
officer of the Company and each former principal financial officer of the Company as applicable) has made all certifications required
by Sections 302 and 906 of the Sarbanes-Oxley Act with respect to all reports, schedules, forms, statements and other documents required
to be filed by it or furnished by it to the Commission. For purposes of the preceding sentence, “principal executive officer”
and “principal financial officer” shall have the meanings given to such terms in the Sarbanes-Oxley Act.
(gg) Finder’s
Fees. Neither the Company nor any of the Subsidiaries has incurred any liability for any finder’s fees, brokerage commissions
or similar payments in connection with the transactions herein contemplated, except as may otherwise exist with respect to the Agent pursuant
to this Agreement.
(hh) Labor
Disputes. No labor disturbance by or dispute with employees of the Company or any of its Subsidiaries exists or, to the knowledge
of the Company, is threatened which would reasonably be expected to result in a Material Adverse Effect.
(ii) Investment
Company Act. Neither the Company nor any of the Subsidiaries is or, after giving effect to the offering and sale of the Placement
Shares, will be an “investment company” or an entity “controlled” by an “investment company,” as such
terms are defined in the Investment Company Act of 1940, as amended (the “Investment Company Act”).
(jj) Operations.
The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance in all material respects with
applicable financial record keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended,
the money laundering statutes of all jurisdictions to which the Company or its Subsidiaries are subject, the rules and regulations
thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any Governmental Authority
(collectively, the “Money Laundering Laws”); and no action, suit or proceeding by or before any Governmental
Authority involving the Company or any of its Subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of
the Company, threatened.
(kk) Off-Balance
Sheet Arrangements. There are no transactions, arrangements and other relationships between and/or among the Company, and/or any of
its affiliates and any unconsolidated entity, including, but not limited to, any structured finance, special purpose or limited purpose
entity (each, an “Off-Balance Sheet Transaction”) that could reasonably be expected to affect materially the
Company’s liquidity or the availability of or requirements for its capital resources, including those Off-Balance Sheet Transactions
described in the Commission’s Statement about Management’s Discussion and Analysis of Financial Conditions and Results of
Operations (Release Nos. 33-8056; 34-45321; FR-61), required to be described in the Prospectus which have not been described as required.
(ll) Underwriter
Agreements. The Company is not a party to any other agreement with an agent or underwriter for any other “at the market”
or continuous equity transaction.
(mm) ERISA.
To the knowledge of the Company, each material employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement
Income Security Act of 1974, as amended (“ERISA”), that is maintained, administered or contributed to by the
Company or any of its affiliates for employees or former employees of the Company and any of its Subsidiaries has been maintained in material
compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited
to ERISA and the Internal Revenue Code of 1986, as amended (the “Code”); no prohibited transaction, within the
meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred which would result in a material liability to the
Company with respect to any such plan excluding transactions effected pursuant to a statutory or administrative exemption; and for each
such plan that is subject to the funding rules of Section 412 of the Code or Section 302 of ERISA, no “accumulated
funding deficiency” as defined in Section 412 of the Code has been incurred, whether or not waived, and the fair market value
of the assets of each such plan (excluding for these purposes accrued but unpaid contributions) exceeds the present value of all benefits
accrued under such plan determined using reasonable actuarial assumptions, except where such deficiency or insufficient asset value would
not reasonably be expect to result in a Material Adverse Effect.
(nn) Forward-Looking
Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the
Exchange Act) (a “Forward-Looking Statement”) contained in the Registration Statement and the Prospectus has
been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.
(oo) Agent
Purchases. The Company acknowledges and agrees that the Agent has informed the Company that the Agent may, to the extent permitted
under the Securities Act and the Exchange Act, purchase and sell Common Stock for its own account while this Agreement is in effect, provided,
that the Company shall not be deemed to have authorized or consented to any such purchases or sales by the Agent.
(pp) Margin
Rules. Neither the issuance, sale and delivery of the Placement Shares nor the application of the proceeds thereof by the Company
as described in the Registration Statement and the Prospectus will violate Regulation T, U or X of the Board of Governors of the Federal
Reserve System or any other regulation of such Board of Governors.
(qq) Insurance.
The Company and each of its Subsidiaries carry, or are covered by, insurance in such amounts and covering such risks as the Company and
each of its Subsidiaries reasonably believe are adequate for the conduct of their properties and as is customary for companies engaged
in similar businesses in similar industries.
(rr) No
Improper Practices. (i) Neither the Company nor the Subsidiaries, nor any director, officer, or employee of the Company or any
Subsidiary nor, to the Company’s knowledge, any agent, affiliate or other person acting on behalf of the Company or any Subsidiary
has, in the past five years, made any unlawful contributions to any candidate for any political office (or failed fully to disclose any
contribution in violation of applicable law) or made any contribution or other payment to any official of, or candidate for, any federal,
state, municipal, or foreign office or other person charged with similar public or quasi-public duty in violation of any applicable law
or of the character required to be disclosed in the Prospectus; (ii) no relationship, direct or indirect, exists between or among
the Company or any Subsidiary or, to the Company’s knowledge, any affiliate of any of them, on the one hand, and the directors,
officers and stockholders of the Company or any Subsidiary, on the other hand, that is required by the Securities Act to be described
in the Registration Statement and the Prospectus that is not so described; (iii) no relationship, direct or indirect, exists between
or among the Company or any Subsidiary or any affiliate of them, on the one hand, and the directors, officers, or stockholders of the
Company or any Subsidiary, on the other hand, that is required by the rules of FINRA to be described in the Registration Statement
and the Prospectus that is not so described; (iv) except as described in the Registration Statement and the Prospectus, there are
no material outstanding loans or advances or material guarantees of indebtedness by the Company or any Subsidiary to or for the benefit
of any of their respective officers or directors or any of the members of the families of any of them; and (v) the Company has not
offered, or caused any placement agent to offer, Common Stock to any person with the intent to influence unlawfully (A) a customer
or supplier of the Company or any Subsidiary to alter the customer’s or supplier’s level or type of business with the Company
or any Subsidiary or (B) a trade journalist or publication to write or publish favorable information about the Company or any Subsidiary
or any of their respective products or services, and, (vi) neither the Company nor any Subsidiary nor, to the Company’s knowledge,
any director, officer or employee of the Company or any Subsidiary, or any agent, affiliate or other person acting on behalf of the Company
or any Subsidiary has (A) violated or is in violation of any applicable provision of the U.S. Foreign Corrupt Practices Act of 1977,
as amended, or any other applicable anti-bribery or anti-corruption law (collectively, “Anti-Corruption Laws”),
or (B) promised, offered, provided, attempted to provide or authorized the provision of anything of value, directly or indirectly,
to any person for the purpose of obtaining or retaining business, influencing any act or decision of the recipient, or securing any improper
advantage, or made any payment of funds of the Company or any Subsidiary or received or retained any funds in violation of any Anti-Corruption
Laws.
(ss) Status
Under the Securities Act. The Company was not and is not an ineligible issuer as defined in Rule 405 under the Securities Act
at the times specified in Rules 164 and 433 under the Securities Act in connection with the offering of the Placement Shares.
(tt) No
Misstatement or Omission in an Issuer Free Writing Prospectus. Each Issuer Free Writing Prospectus, as of its issue date and as of
each Applicable Time (as defined in Section 23 below), did not, does not and will not include any information that conflicted,
conflicts or will conflict with the information contained in the Registration Statement or the Prospectus, including any incorporated
document deemed to be a part thereof that has not been superseded or modified. The foregoing sentence does not apply to statements in
or omissions from any Issuer Free Writing Prospectus based upon and in conformity with written information furnished to the Company by
the Agent specifically for use therein.
(uu) No
Conflicts. Neither the execution of this Agreement, nor the issuance, offering or sale of the Placement Shares, nor the consummation
of any of the transactions contemplated herein and therein, nor the compliance by the Company with the terms and provisions hereof and
thereof will conflict with, or will result in a breach of, any of the terms and provisions of, or has constituted or will constitute a
default under, or has resulted in or will result in the creation or imposition of any lien, charge or encumbrance upon any property or
assets of the Company pursuant to the terms of any contract or other agreement to which the Company may be bound or to which any of the
property or assets of the Company is subject, except (i) such conflicts, breaches or defaults as may have been waived and (ii) such
conflicts, breaches and defaults that would not have a Material Adverse Effect; nor will such action result (x) in any violation
of the provisions of the organizational or governing documents of the Company, or (y) in any material violation of the provisions
of any statute or any order, rule or regulation applicable to the Company or of any Governmental Authority having jurisdiction over
the Company.
(vv) Sanctions.
(i) The Company represents that, neither the Company nor any of its Subsidiaries (collectively, the “Entity”)
nor, to the Company’s knowledge, any director, officer, employee, agent, affiliate or representative of the Entity, is a government,
individual, or entity (in this paragraph (vv), “Person”) that is, or is owned or controlled by a Person that
is:
(A) the
subject of any sanctions administered or enforced by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”),
the United Nations Security Council, the European Union, His Majesty’s Treasury, or other relevant sanctions authorities, including,
without limitation, designation on OFAC’s Specially Designated Nationals and Blocked Persons List or OFAC’s Foreign Sanctions
Evaders List (as amended, collectively, “Sanctions”), nor
(B) located,
organized or resident in a country or territory that is the subject of Sanctions that broadly prohibit dealings with that country or territory
(including, without limitation, Cuba, Iran, North Korea, Syria, the so-called Donetsk People’s Republic, the so-called Luhansk
People’s Republic and the Crimea Region of the Ukraine) (the “Sanctioned Countries”).
(ii) The
Entity represents and covenants that it will not, directly or indirectly, use the proceeds of the offering, or lend, contribute or otherwise
make available such proceeds to any subsidiary, joint venture partner or other Person:
(A) to
fund or facilitate any activities or business of or with any Person or in any country or territory that, at the time of such funding or
facilitation, is the subject of Sanctions or is a Sanctioned Country; or
(B) in
any other manner that will result in a violation of Sanctions by any Person (including any Person participating in the offering, whether
as underwriter, advisor, investor or otherwise).
(iii) The
Entity represents and covenants that, except as detailed in the Registration Statement and the Prospectus, for the past 5 years, it has
not engaged in, is not now engaging in, and will not engage in, any dealings or transactions with any Person, or in any country or territory,
that at the time of the dealing or transaction is or was the subject of Sanctions or is or was a Sanctioned Country.
(ww) Stock
Transfer Taxes. On each Settlement Date, all stock transfer or other taxes (other than income taxes) which are required to be paid
in connection with the sale and transfer of the Placement Shares to be sold hereunder will be, or will have been, fully paid or provided
for by the Company and all laws imposing such taxes will be or will have been fully complied with in all material respects.
(xx) Compliance
with Laws. Except as described in the Registration Statement or Prospectus, with respect to products it still owns or markets, each
of the Company and its Subsidiaries (A) is and at all times has been in compliance with all statutes, rules, or regulations applicable
to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer
for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (“Applicable
Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect;
(B) has not been the target of any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence
or notice from the FDA or any other Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses,
certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws
(“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in
full force and effect and are not in material violation of any term of any such Authorizations; (D) has not received notice of any
claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third
party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and has no knowledge that
any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or
proceeding; (E) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit,
suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; (F) has
filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and
supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented
by a subsequent submission); and (G) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be
initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear healthcare
provider” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product
defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any such notice
or action.
(yy) Statistical
and Market-Related Data. The statistical, demographic and market-related data included in the Registration Statement and Prospectus
are based on or derived from sources that the Company believes to be reliable and accurate in all material respects or represent the Company’s
good faith estimates that are made on the basis of data derived from such sources.
(zz) Cybersecurity.
The Company and its subsidiaries’ information technology assets and equipment, computers, systems, networks, hardware, software,
websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform
as required in connection with the operation of the business of the Company as currently conducted, free and clear of all material bugs,
errors, defects, Trojan horses, time bombs, malware and other corruptants, except where such inadequacy or failure to operate or perform
would not reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries have implemented and maintained commercially
reasonable physical, technical and administrative controls, policies, procedures, and safeguards designed to maintain and protect their
material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and all sensitive,
confidential or regulated data (“Confidential Data”) and “Personal Data” (defined below) used in
connection with their businesses, except where the failure to so maintain would not reasonably be expected to have a Material Adverse
Effect. “Personal Data” means (i) a natural person’s name, street address, telephone number, e-mail
address, photograph, social security number or tax identification number, driver’s license number, passport number, credit card
number, bank information, or customer or account number; (ii) any information which would qualify as “personally identifying
information” under the Federal Trade Commission Act, as amended; (iii) “personal data” as defined by the GDPR;
(iv) any information which would qualify as “protected health information” under the Health Insurance Portability and
Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”);
(v) any “personal information” as defined by the California Consumer Privacy Act (“CCPA”) and
(vi) any other piece of information that allows the identification of such natural person, or his or her family, or permits the collection
or analysis of any data related to an identified person’s health or sexual orientation. There have been no breaches, violations,
outages or unauthorized uses of or accesses to same, nor any incidents under internal review or investigations relating to the same, except
for those that have been remedied without material cost or liability or the duty to notify any other person or would not reasonably be
expected to have a Material Adverse Effect . The Company and its subsidiaries are presently in material compliance with all applicable
laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority,
internal written policies and contractual obligations relating to the privacy and security of IT Systems, Confidential Data, and Personal
Data and to the protection of such IT Systems, Confidential Data, and Personal Data from unauthorized use, access, misappropriation or
modification.
(aaa) Compliance
with Data Privacy Laws. The Company and its subsidiaries are, and at all times in the past three (3) years, were, in material
compliance with all applicable state and federal data privacy and security laws and regulations, including without limitation HIPAA, CCPA,
and the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) (collectively, the “Privacy
Laws”). The Company has in place, complies with, and takes appropriate steps to promote compliance in all material respects
with their policies and procedures relating to data privacy and security and the collection, storage, use, processing, disclosure, handling,
and analysis of Personal Data and Confidential Data (the “Policies”). The Company has at all times made all
disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such disclosures
made or contained in any Policy have been inaccurate or in violation of any applicable laws and regulatory rules or requirements
in any material respect. The Company further certifies that neither it nor any subsidiary: (i) has received notice of any actual
or potential material liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge
of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying
for, in whole or in part, any material investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is
a party to any order, decree, or agreement that imposes any material obligation or liability under any Privacy Law.
(bbb) Emerging
Growth Company Status. From the time of the initial filing of the Company’s first registration statement with the Commission
through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of
the Securities Act (an “Emerging Growth Company”).
Any certificate signed by
an officer of the Company and delivered to the Agent or to counsel for the Agent pursuant to or in connection with this Agreement shall
be deemed to be a representation and warranty by the Company, as applicable, to the Agent as to the matters set forth therein.
7. Covenants
of the Company. The Company covenants and agrees with the Agent that:
(a) Registration
Statement Amendments. After the date of this Agreement and during any period in which a Prospectus relating to any Placement Shares
is required to be delivered by the Agent under the Securities Act (including in circumstances where such requirement may be satisfied
pursuant to Rule 172 under the Securities Act or similar rule), (i) the Company will notify the Agent promptly of the time when
any subsequent amendment relating to the Placement Shares to the Registration Statement, other than documents incorporated by reference,
has been filed with the Commission and/or has become effective or any subsequent supplement to the Prospectus has been filed and of any
request by the Commission for any amendment or supplement relating to the Placement Shares to the Registration Statement or Prospectus
or for additional information, (ii) the Company will prepare and file with the Commission, promptly upon the Agent’s request,
any amendments or supplements to the Registration Statement or Prospectus that, in the Agent’s reasonable opinion, may be necessary
or advisable in connection with the distribution of the Placement Shares by the Agent (provided, however, that the failure
of the Agent to make such request shall not relieve the Company of any obligation or liability hereunder, or affect the Agent’s
right to rely on the representations and warranties made by the Company in this Agreement and provided, further, that the
only remedy the Agent shall have with respect to the failure to make such filing shall be to cease making sales under this Agreement until
such amendment or supplement is filed); (iii) the Company will not file any amendment or supplement to the Registration Statement
or Prospectus relating to the Placement Shares, other than documents incorporated by reference, unless a copy thereof has been submitted
to Agent within a reasonable period of time before the filing and the Agent has not reasonably objected thereto (provided, however,
that the failure of the Agent to make such objection shall not relieve the Company of any obligation or liability hereunder, or affect
the Agent’s right to rely on the representations and warranties made by the Company in this Agreement and provided, further,
that the only remedy the Agent shall have with respect to the failure by the Company to obtain such consent shall be to cease making sales
under this Agreement) and the Company will furnish to the Agent at the time of filing thereof a copy of any document that upon filing
is deemed to be incorporated by reference into the Registration Statement or Prospectus, except for those documents available via EDGAR;
and (iv) the Company will cause each amendment or supplement to the Prospectus to be filed with the Commission as required pursuant
to the applicable paragraph of Rule 424(b) of the Securities Act or, in the case of any document to be incorporated therein
by reference, to be filed with the Commission as required pursuant to the Exchange Act, within the time period prescribed (the determination
to file or not file any amendment or supplement with the Commission under this Section 7(a), based on the Company’s
reasonable opinion or reasonable objections, shall be made exclusively by the Company).
(b) Notice
of Commission Stop Orders. The Company will advise the Agent, promptly after it receives notice or obtains knowledge thereof, of the
issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement, of the
suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction, or of the initiation or threatening
of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop
order or to obtain its withdrawal if such a stop order should be issued. The Company will advise the Agent promptly after it receives
any request by the Commission for any amendments to the Registration Statement or any amendment or supplements to the Prospectus or any
Issuer Free Writing Prospectus or for additional information related to the offering of the Placement Shares or for additional information
related to the Registration Statement, the Prospectus or any Issuer Free Writing Prospectus.
(c) Delivery
of Prospectus; Subsequent Changes. During any period in which a Prospectus relating to the Placement Shares is required to be delivered
by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares, (including in circumstances where such
requirement may be satisfied pursuant to Rule 172 under the Securities Act or similar rule), the Company will comply with all requirements
imposed upon it by the Securities Act, as from time to time in force, and to file on or before their respective due dates all reports
and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Sections 13(a),
13(c), 14, 15(d) or any other provision of or under the Exchange Act. If the Company has omitted any information from the Registration
Statement pursuant to Rule 430B under the Securities Act, it will use its commercially reasonable efforts to comply with the provisions
of and make all requisite filings with the Commission pursuant to said Rule 430B and to notify the Agent promptly of all such filings
if not available on EDGAR. If during such period any event occurs as a result of which the Prospectus as then amended or supplemented
would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the
light of the circumstances then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration
Statement or Prospectus to comply with the Securities Act, the Company will promptly notify the Agent to suspend the offering of Placement
Shares during such period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of
the Company) so as to correct such statement or omission or effect such compliance.
(d) Listing
of Placement Shares. Prior to the date of the first Placement Notice, the Company will use its commercially reasonable efforts to
cause the Placement Shares to be listed on the Exchange.
(e) Delivery
of Registration Statement and Prospectus. The Company will furnish to the Agent and its counsel (at the expense of the Company) copies
of the Registration Statement, the Prospectus (including all documents incorporated by reference therein) and all amendments and supplements
to the Registration Statement or Prospectus that are filed with the Commission during any period in which a Prospectus relating to the
Placement Shares is required to be delivered under the Securities Act (including all documents filed with the Commission during such period
that are deemed to be incorporated by reference therein), in each case as soon as reasonably practicable and in such quantities as the
Agent may from time to time reasonably request and, at the Agent’s request, will also furnish copies of the Prospectus to each exchange
or market on which sales of the Placement Shares may be made; provided, however, that the Company shall not be required
to furnish any document (other than the Prospectus) to the Agent to the extent such document is available on EDGAR.
(f) Earning
Statement. The Company will make generally available to its security holders as soon as practicable (which may be via filing on EDGAR),
but in any event not later than 15 months after the end of the Company’s current fiscal quarter, an earning statement covering a
12-month period that satisfies the provisions of Section 11(a) and Rule 158 of the Securities Act.
(g) Use
of Proceeds. The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.”
(h) Notice
of Other Sales. Without the prior written consent of the Agent, the Company will not, directly or indirectly, offer to sell, sell,
contract to sell, grant any option to sell or otherwise dispose of any Common Stock (other than the Placement Shares offered pursuant
to this Agreement) or securities convertible into or exchangeable for Common Stock, warrants or any rights to purchase or acquire, Common
Stock during the period beginning on the fifth (5th) Trading Day immediately prior to the date on which any Placement Notice
is delivered to Agent hereunder and ending on the fifth (5th) Trading Day immediately following the final Settlement Date with
respect to Placement Shares sold pursuant to such Placement Notice (or, if the Placement Notice has been terminated or suspended prior
to the sale of all Placement Shares covered by a Placement Notice, the date of such suspension or termination); and will not directly
or indirectly in any other “at the market” or continuous equity transaction offer to sell, sell, contract to sell, grant any
option to sell or otherwise dispose of any Common Stock (other than the Placement Shares offered pursuant to this Agreement) or securities
convertible into or exchangeable for Common Stock, warrants or any rights to purchase or acquire, Common Stock prior to the sixtieth (60th)
day immediately following the termination of this Agreement; provided, however, that such restrictions will not be required
in connection with the Company’s issuance or sale of (i) Common Stock, options to purchase, or rights to acquire, Common Stock
or Common Stock issuable upon the exercise or vesting of options or rights to acquire Common Stock, pursuant to any employee or director
stock option or benefits plan, stock ownership plan or dividend reinvestment plan (but not Common Stock subject to a waiver to exceed
plan limits in its dividend reinvestment plan) of the Company whether now in effect or hereafter implemented, (ii) Common Stock issuable
upon conversion of securities or the exercise of warrants, options or other rights in effect or outstanding, and disclosed in filings
by the Company available on EDGAR or otherwise in writing to the Agent and (iii) Common Stock or securities convertible into or exchangeable
for shares of Common Stock as consideration for mergers, acquisitions, loans, other business combinations or research, collaboration,
licensing, joint or other development, marketing or similar strategic alliances or partnerships occurring after the date of this Agreement
which are not issued for equity capital raising purposes.
(i) Change
of Circumstances. The Company will, at any time during the pendency of a Placement Notice, advise the Agent promptly after it shall
have received notice or obtained knowledge thereof, of any information or fact that would alter or affect in any material respect any
opinion, certificate, letter or other document required to be provided to the Agent pursuant to this Agreement.
(j) Due
Diligence Cooperation. The Company will cooperate with any reasonable due diligence review conducted by the Agent or its representatives
in connection with the transactions contemplated hereby, including, without limitation, providing information and making available documents
and senior corporate officers, during regular business hours and at the Company’s principal offices, as the Agent may reasonably
request.
(k) Required
Filings Relating to Placement of Placement Shares. The Company shall disclose, in its quarterly reports on Form 10-Q and in its
annual report on Form 10-K to be filed by the Company with the Commission from time to time, the number of the Placement Shares sold
through the Agent under this Agreement, and the net proceeds to the Company from the sale of the Placement Shares pursuant to this Agreement
during the relevant quarter or, in the case of an Annual Report on Form 10-K, during the fiscal year covered by such Annual Report
and the fourth quarter of such fiscal year. The Company agrees that on such dates as the Securities Act shall require, the Company will
(i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities
Act (each and every filing date under Rule 424(b), a “Filing Date”), which prospectus supplement will set
forth, within the relevant period, the amount of Placement Shares sold through the Agent, the Net Proceeds to the Company and the compensation
payable by the Company to the Agent with respect to such Placement Shares, and (ii) deliver such number of copies of each such prospectus
supplement to each exchange or market on which such sales were effected as may be required by the rules or regulations of such exchange
or market.
(l) Representation
Dates; Certificate. (1) On or prior to the date of the first Placement Notice and (2) each time the Company:
(i) files the Prospectus relating
to the Placement Shares or amends or supplements (other than a prospectus supplement relating solely to an offering of securities other
than the Placement Shares) the Registration Statement or the Prospectus relating to the Placement Shares by means of a post-effective
amendment, sticker, or supplement but not by means of incorporation of documents by reference into the Registration Statement or the Prospectus
relating to the Placement Shares;
(ii) files an annual report on
Form 10-K under the Exchange Act (including any Form 10-K/A containing amended financial information or a material amendment
to the previously filed Form 10-K);
(iii) files its quarterly reports
on Form 10-Q under the Exchange Act; or
(iv) files a current report on
Form 8-K containing amended financial information (other than information “furnished” pursuant to Items 2.02 or 7.01
of Form 8-K or to provide disclosure pursuant to Item 8.01 of Form 8-K relating to the reclassification of certain properties
as discontinued operations in accordance with Statement of Financial Accounting Standards No. 144) under the Exchange Act (each date
of filing of one or more of the documents referred to in clauses (i) through (iv) shall be a “Representation Date”);
the Company shall furnish the Agent (but in the
case of clause (iv) above only if the Agent reasonably determines that the information contained in such Form 8-K is material)
with a certificate dated the Representation Date, in the form and substance satisfactory to the Agent and its counsel, substantially similar
to the form previously provided to the Agent and its counsel, modified, as necessary, to relate to the Registration Statement and the
Prospectus as amended or supplemented. The requirement to provide a certificate under this Section 7(l) shall be waived
for any Representation Date occurring at a time at which no Placement Notice is pending (including, for purposes of clarity, during which
a Suspension is in effect), which waiver shall continue until the earlier to occur of the date the Company delivers a Placement Notice
hereunder (which for such calendar quarter shall be considered a Representation Date) and the next occurring Representation Date. Notwithstanding
the foregoing, if the Company subsequently decides to sell Placement Shares following a Representation Date when a Suspension was in effect
and did not provide the Agent with a certificate under this Section 7(l), then before the Company delivers the instructions
for the sale of Placement Shares or the Agent sells any Placement Shares pursuant to such instructions, the Company shall provide the
Agent with a certificate in conformity with this Section 7(l) dated as of the date that the Placement Notice is issued.
(m) Legal
Opinion. (1) On or prior to the date of the first Placement Notice and (2) within five (5) Trading Days of each Representation
Date with respect to which the Company is obligated to deliver a certificate pursuant to Section 7(l) for which no waiver
is applicable and excluding the date of this Agreement, the Company shall cause to be furnished to the Agent a written opinion and negative
assurance letter of Kilpatrick Townsend & Stockton LLP (“Company Counsel”) or other counsel reasonably
satisfactory to the Agent, in form and substance reasonably satisfactory to the Agent and its counsel, substantially similar to the form
previously provided to the Agent and its counsel, modified, as necessary, to relate to the Registration Statement and the Prospectus as
then amended or supplemented; provided, that in lieu of such opinions and/or negative assurance letters for subsequent periodic
filings under the Exchange Act, counsel may furnish the Agent with a letter (a “Reliance Letter”) to the effect
that the Agent may rely on a prior opinion and/or negative assurance letter delivered under this Section 7(m) to the
same extent as if it were dated the date of such letter (except that statements in such prior opinion shall be deemed to relate to the
Registration Statement and the Prospectus as amended or supplemented as of the date of the Reliance Letter).
(n) Comfort
Letter. (1) On or prior to the date of the first Placement Notice and (2) within five (5) Trading Days of each Representation
Date with respect to which the Company is obligated to deliver a certificate pursuant to Section 7(l) for which no waiver
is applicable and excluding the date of this Agreement, the Company shall cause its independent registered public accounting firm to furnish
the Agent letters (the “Comfort Letters”), dated the date the Comfort Letter is delivered, which shall meet
the requirements set forth in this Section 7(n); provided, that if reasonably requested by the Agent, the Company shall
cause a Comfort Letter to be furnished to the Agent within ten (10) Trading Days of the date of occurrence of any material transaction
or event requiring the filing of a Current Report on Form 8-K containing financial information ( including the restatement of the
Company’s financial statements). The Comfort Letter from the Company’s independent registered public accounting firm shall
be in a form and substance reasonably satisfactory to the Agent, (i) confirming that they are an independent registered public accounting
firm within the meaning of the Securities Act and the Public Company Accounting Oversight Board (“PCAOB”), (ii) stating,
as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily covered
by accountants’ “comfort letters” to underwriters in connection with registered public offerings (the first such letter,
the “Initial Comfort Letter”) and (iii) updating the Initial Comfort Letter with any information that would
have been included in the Initial Comfort Letter had it been given on such date and modified as necessary to relate to the Registration
Statement and the Prospectus, as amended and supplemented to the date of such letter.
(o) Market
Activities; Compliance with Regulation M. The Company will not, directly or indirectly, (i) take any action designed to cause
or result in, or that constitutes or would reasonably be expected to constitute, the stabilization or manipulation of the price of any
security of the Company to facilitate the sale or resale of Common Stock or (ii) sell, bid for, or purchase Common Stock in violation
of Regulation M, or pay anyone any compensation for soliciting purchases of the Placement Shares other than the Agent.
(p) Investment
Company Act. The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor any of its Subsidiaries
will be or become, at any time prior to the termination of this Agreement, required to register as an “investment company,”
as such term is defined in the Investment Company Act.
(q) No
Offer to Sell. Other than the Prospectus and an Issuer Free Writing Prospectus approved in advance by the Company and the Agent in
its capacity as agent hereunder, neither the Agent nor the Company (including its agents and representatives, other than the Agent in
its capacity as such) will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under
the Securities Act), required to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Placement
Shares hereunder.
(r) Blue
Sky and Other Qualifications. The Company will use its commercially reasonable efforts, in cooperation with the Agent, to
qualify the Placement Shares for offering and sale, or to obtain an exemption for the Placement Shares to be offered and sold, under the
applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Agent may designate and to maintain such
qualifications and exemptions in effect for so long as required for the distribution of the Placement Shares (but in no event for less
than one year from the date of this Agreement); provided, however, that the Company shall not be obligated to file any general
consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not
so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject.
In each jurisdiction in which the Placement Shares have been so qualified or exempt, the Company will file such statements and reports
as may be required by the laws of such jurisdiction to continue such qualification or exemption, as the case may be, in effect for so
long as required for the distribution of the Placement Shares (but in no event for less than one year from the date of this Agreement).
(s) Sarbanes-Oxley
Act. The Company and the Subsidiaries will maintain and keep accurate books and records reflecting their assets and maintain internal
accounting controls in a manner designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with GAAP and including those policies and procedures that (i) pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets
of the Company, (ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of the Company’s
consolidated financial statements in accordance with GAAP, (iii) that receipts and expenditures of the Company are being made only
in accordance with management’s and the Company’s directors’ authorization, and (iv) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have
a material effect on its financial statements. The Company and the Subsidiaries will maintain such controls and other procedures, including,
without limitation, those required by Sections 302 and 906 of the Sarbanes-Oxley Act, and the applicable regulations thereunder that are
designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms,
including, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in
the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including
its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure and to ensure that material information relating to the Company or the Subsidiaries is made known
to them by others within those entities, particularly during the period in which such periodic reports are being prepared.
(t) Secretary’s
Certificate; Further Documentation. On or prior to the date of the first Placement Notice, the Company shall deliver to the Agent
a certificate of the Secretary of the Company and attested to by an executive officer of the Company, dated as of such date, certifying
as to (i) the Certificate of Incorporation of the Company, (ii) the By-laws of the Company, (iii) the resolutions of the
Board of Directors of the Company authorizing the execution, delivery and performance of this Agreement and the issuance of the Placement
Shares and (iv) the incumbency of the officers duly authorized to execute this Agreement and the other documents contemplated by
this Agreement. Within five (5) Trading Days of each Representation Date, the Company shall have furnished to the Agent such further
information, certificates and documents as the Agent may reasonably request.
(u) Emerging
Growth Company Status. The Company will cease to be an Emerging Growth Company on December 31, 2025. The Company will promptly
notify the Agent if the Company ceases to be an Emerging Growth Company earlier than such date.
8. Payment
of Expenses. The Company will pay all expenses incident to the performance of its obligations under this Agreement, including (i) the
preparation and filing of the Registration Statement, including any fees required by the Commission, and the printing or electronic delivery
of the Prospectus as originally filed and of each amendment and supplement thereto, in such number as the Agent shall deem necessary,
(ii) the printing and delivery to the Agent of this Agreement and such other documents as may be required in connection with the
offering, purchase, sale, issuance or delivery of the Placement Shares, (iii) the preparation, issuance and delivery of the certificates,
if any, for the Placement Shares to the Agent, including any stock or other transfer taxes and any capital duties, stamp duties or other
duties or taxes payable upon the sale, issuance or delivery of the Placement Shares to the Agent, (iv) the fees and disbursements
of the counsel, accountants and other advisors to the Company, (v) the reasonable fees and expenses of Agent including but not limited
to the reasonable fees and expenses of the counsel to the Agent, payable upon the execution of this Agreement, (a) in an amount not
to exceed $75,000 in connection with the execution of this Agreement, (b) in an amount not to exceed $25,000 per calendar quarter
thereafter payable in connection with each Representation Date with respect to which the Company is obligated to deliver a certificate
pursuant to Section 7(l) for which no waiver is applicable and excluding the date of this Agreement, and (c) in
an amount not to exceed $40,000 for each program “refresh” (filing of a new registration statement, prospectus or prospectus
supplement relating to the Placement Shares and/or an amendment of this Agreement) executed pursuant to this Agreement, (vi) the
qualification or exemption of the Placement Shares under state securities laws in accordance with the provisions of Section 7(r) hereof,
including filing fees, but excluding fees of the Agent’s counsel, (vii) the printing and delivery to the Agent of copies of
any Permitted Free Writing Prospectus and the Prospectus and any amendments or supplements thereto in such number as the Agent shall deem
necessary, (viii) the preparation, printing and delivery to the Agent of copies of any blue sky survey, (ix) the fees and expenses
of the transfer agent and registrar for the Common Stock, (x) the filing and other fees incident to any review by FINRA of the terms
of the sale of the Placement Shares including the fees of the Agent’s counsel (subject to the cap, set forth in clause (v)(a) above),
and (xi) the fees and expenses incurred in connection with the listing of the Placement Shares on the Exchange. The Company agrees
to pay the fees and expenses of counsel to the Agent set forth in clause (v) above by wire transfer of immediately available funds
directly to such counsel upon presentation of an invoice containing the requisite payment information prepared by such counsel.
9. Conditions
to Agent’s Obligations. The obligations of the Agent hereunder with respect to a Placement will be subject to the continuing
accuracy and completeness in all material respects of the representations and warranties made by the Company herein, to the due performance
in all material respects by the Company of its obligations hereunder, to the completion by the Agent of a due diligence review satisfactory
to it in its reasonable judgment, and to the continuing satisfaction (or waiver by the Agent in its sole discretion) of the following
additional conditions:
(a) Registration
Statement Effective. The Registration Statement shall have become effective and shall be available for the (i) resale of all
Placement Shares issued to the Agent and not yet sold by the Agent and (ii) sale of all Placement Shares contemplated to be issued
by any Placement Notice.
(b) No
Material Notices. None of the following events shall have occurred and be continuing: (i) receipt by the Company of any request
for additional information from the Commission or any other federal or state Governmental Authority during the period of effectiveness
of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration Statement
or the Prospectus; (ii) the issuance by the Commission or any other federal or state Governmental Authority of any stop order suspending
the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company
of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Placement Shares
for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event
that makes any statement of a material fact made in the Registration Statement or the Prospectus or any document incorporated or deemed
to be incorporated therein by reference untrue in any material respect or that requires the making of any changes in the Registration
Statement, the Prospectus or documents so that, in the case of the Registration Statement, it will not contain an untrue statement of
a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading
and, that in the case of the Prospectus, it will not contain an untrue statement of a material fact or omit to state a material fact required
to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(c) No
Misstatement or Material Omission. Agent shall not have advised the Company that the Registration Statement or Prospectus, or any
amendment or supplement thereto, contains an untrue statement of fact that in the Agent’s reasonable opinion is material, or omits
to state a fact that in the Agent’s reasonable opinion is material and is required to be stated therein or is necessary to make
the statements therein not misleading.
(d) Material
Changes. Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall
not have been any any Material Adverse Effect or any development that would reasonably be expected to cause a Material Adverse Effect,
or a downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities)
by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating of
any of the Company’s securities (other than asset backed securities), the effect of which, in the case of any such action by a rating
organization described above, in the reasonable judgment of the Agent (without relieving the Company of any obligation or liability it
may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of the Placement Shares on
the terms and in the manner contemplated in the Prospectus.
(e) Legal
Opinions. The Agent shall have received the opinions and negative assurance letters required to be delivered pursuant to Section 7(m) on
or before the date on which such delivery of such opinions and negative assurance letters is required pursuant to Section 7(m).
(f) Comfort
Letter. The Agent shall have received the Comfort Letter required to be delivered pursuant to Section 7(n) on or
before the date on which such delivery of such Comfort Letter is required pursuant to Section 7(n).
(g) Representation
Date Certificate. The Agent shall have received the certificate required to be delivered pursuant to Section 7(l) on
or before the date on which delivery of such certificate is required pursuant to Section 7(l).
(h) Secretary’s
Certificate. The Agent shall have received the certificate required to be delivered pursuant to Section 7(t) on or
before the date on which delivery of such certificate is required pursuant to Section 7(t).
(i) No
Suspension. Trading in the Common Stock shall not have been suspended on the Exchange and the Common Stock shall not have been delisted
from the Exchange.
(j) Other
Materials. On each date on which the Company is required to deliver a certificate pursuant to Section 7(l), the Company
shall have furnished to the Agent such appropriate further information, opinions, certificates, letters and other documents as the Agent
may reasonably request.
(k) Securities
Act Filings Made. All filings with the Commission required by Rule 424 under the Securities Act to have been filed prior to the
issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing by Rule 424.
(l) Approval
for Listing. The Placement Shares shall either have been (i) approved for listing on the Exchange, subject only to notice of
issuance, or (ii) the Company shall have filed an application for listing of the Placement Shares on the Exchange at, or prior to,
the issuance of any Placement Notice and the Exchange shall have reviewed such application and not provided any objections thereto.
(m) FINRA.
If applicable, FINRA shall have raised no objection to the terms of this offering and the amount of compensation allowable or payable
to the Agent as described in the Prospectus.
(n) No
Termination Event. There shall not have occurred any event that would permit the Agent to terminate this Agreement pursuant to Section 12(a).
10. Indemnification
and Contribution.
(a) Company
Indemnification. The Company agrees to indemnify and hold harmless the Agent, its affiliates and their respective partners, members,
directors, officers, employees and agents and each person, if any, who controls the Agent or any affiliate within the meaning of Section 15
of the Securities Act or Section 20 of the Exchange Act as follows:
(i) against
any and all loss, liability, claim, damage and expense whatsoever, as incurred, joint or several, arising out of or based upon any untrue
statement or alleged untrue statement of a material fact contained in the Registration Statement (or any amendment thereto), or the omission
or alleged omission therefrom of a material fact required to be stated therein or necessary to make the statements therein not misleading,
or arising out of any untrue statement or alleged untrue statement of a material fact included in any related Issuer Free Writing Prospectus
or the Prospectus (or any amendment or supplement thereto), or the omission or alleged omission therefrom of a material fact necessary
in order to make the statements therein, in the light of the circumstances under which they were made, not misleading;
(ii) against
any and all loss, liability, claim, damage and expense whatsoever, as incurred, joint or several, to the extent of the aggregate amount
paid in settlement of any litigation, or any investigation or proceeding by any Governmental Authority, commenced or threatened, or of
any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission; provided
that (subject to Section 10(d) below) any such settlement is effected with the written consent of the Company, which
consent shall not unreasonably be delayed or withheld; and
(iii) against
any and all expense whatsoever, as incurred (including the reasonable fees and disbursements of counsel), reasonably incurred in investigating,
preparing or defending against any litigation, or any investigation or proceeding by any Governmental Authority, commenced or threatened,
or any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission (whether or
not a party), to the extent that any such expense is not paid under (i) or (ii) above,
provided,
however, that this indemnity agreement shall not apply to any loss, liability, claim, damage or expense to the extent arising out
of any untrue statement or omission or alleged untrue statement or omission made solely in reliance upon and in conformity with the Agent
Information (as defined below).
(b) Agent
Indemnification. Agent agrees to indemnify and hold harmless the Company and its directors and each officer of the Company who signed
the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the Securities
Act or Section 20 of the Exchange Act against any and all loss, liability, claim, damage and expense described in the indemnity contained
in Section 10(a), as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions,
made in the Registration Statement (or any amendments thereto), the Prospectus (or any amendment or supplement thereto) or any Issuer
Free Writing Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with information relating to the Agent
and furnished to the Company in writing by the Agent expressly for use therein. The Company hereby acknowledges that the only information
that the Agent has furnished to the Company expressly for use in the Registration Statement, the Prospectus, any Sales Prospectus or any
Issuer Free Writing Prospectus (or any amendment or supplement thereto) are the statements set forth in the first sentence of the fifth
paragraph and the seventh paragraph under the caption “Plan of Distribution” in the Prospectus (the “Agent Information”).
(c) Procedure.
Any party that proposes to assert the right to be indemnified under this Section 10 will, promptly after receipt of notice
of commencement of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under
this Section 10, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served,
but the omission so to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might
have to any indemnified party otherwise than under this Section 10 and (ii) any liability that it may have to any indemnified
party under the foregoing provision of this Section 10 unless, and only to the extent that, such omission results in the forfeiture
of substantive rights or defenses by the indemnifying party. If any such action is brought against any indemnified party and it notifies
the indemnifying party of its commencement, the indemnifying party will be entitled to participate in and, to the extent that it elects
by delivering written notice to the indemnified party promptly after receiving notice of the commencement of the action from the indemnified
party, jointly with any other indemnifying party similarly notified, to assume the defense of the action, with counsel reasonably satisfactory
to the indemnified party, and after notice from the indemnifying party to the indemnified party of its election to assume the defense,
the indemnifying party will not be liable to the indemnified party for any other legal expenses except as provided below and except for
the reasonable costs of investigation subsequently incurred by the indemnified party in connection with the defense. The indemnified party
will have the right to employ its own counsel in any such action, but the fees, expenses and other charges of such counsel will be at
the expense of such indemnified party unless (1) the employment of counsel by the indemnified party has been authorized in writing
by the indemnifying party, (2) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal
defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party,
(3) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and
the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of
the indemnified party) or (4) the indemnifying party has not in fact employed counsel to assume the defense of such action or counsel
reasonably satisfactory to the indemnified party, in each case, within a reasonable time after receiving notice of the commencement of
the action; in each of which cases the reasonable fees, disbursements and other charges of counsel will be at the expense of the indemnifying
party or parties. It is understood that the indemnifying party or parties shall not, in connection with any proceeding or related proceedings
in the same jurisdiction, be liable for the reasonable fees, disbursements and other charges of more than one separate firm (plus local
counsel) admitted to practice in such jurisdiction at any one time for all such indemnified party or parties. All such fees, disbursements
and other charges will be reimbursed by the indemnifying party promptly as they are incurred after the indemnifying party has received
a written invoice relating to such fees, disbursements and other charges. An indemnifying party will not, in any event, be liable for
any settlement of any action or claim effected without its written consent. No indemnifying party shall, without the prior written consent
of each indemnified party, settle or compromise or consent to the entry of any judgment in any pending or threatened claim, action or
proceeding relating to the matters contemplated by this Section 10 (whether or not any indemnified party is a party thereto),
unless such settlement, compromise or consent (1) includes an express and unconditional release of each indemnified party, in form
and substance reasonably satisfactory to such indemnified party, from all liability arising out of such litigation, investigation, proceeding
or claim and (2) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of
any indemnified party. Indemnified parties will reasonably cooperate with the indemnifying party or indemnifying parties in the investigation
and defense of any claim for which indemnification is sought hereunder.
(d) Settlement
Without Consent if Failure to Reimburse. If an indemnified party shall have requested in writing an indemnifying party to
reimburse the indemnified party for reasonable fees and expenses of counsel for which it is entitled to reimbursement hereunder, such
indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by Section 10(a)(ii) effected
without its written consent if (1) such settlement is entered into more than 45 days after receipt by such indemnifying party of
the aforesaid request, (2) such indemnifying party shall have received written notice of the terms of such settlement at least 30
days prior to such settlement being entered into and (3) such indemnifying party shall not have reimbursed such indemnified party
in accordance with such request prior to the date of such settlement.
(e) Contribution.
In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing paragraphs
of this Section 10 is applicable in accordance with its terms but for any reason is held to be unavailable or insufficient
from the Company or the Agent, the Company and the Agent will contribute to the total losses, claims, liabilities, expenses and damages
(including any investigative, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any
action, suit or proceeding or any claim asserted) to which the Company and the Agent may be subject in such proportion as shall be appropriate
to reflect the relative benefits received by the Company on the one hand and the Agent on the other hand. The relative benefits received
by the Company on the one hand and the Agent on the other hand shall be deemed to be in the same proportion as the total net proceeds
from the sale of the Placement Shares (before deducting expenses) received by the Company bear to the total compensation received by the
Agent from the sale of Placement Shares on behalf of the Company. If, but only if, the allocation provided by the foregoing sentence is
not permitted by applicable law, the allocation of contribution shall be made in such proportion as is appropriate to reflect not only
the relative benefits referred to in the foregoing sentence but also the relative fault of the Company, on the one hand, and the Agent,
on the other hand, with respect to the statements or omission that resulted in such loss, claim, liability, expense or damage, or action
in respect thereof, as well as any other relevant equitable considerations with respect to such offering. Such relative fault shall be
determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or omission or alleged
omission to state a material fact relates to information supplied by the Company or the Agent, the intent of the parties and their relative
knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Agent agree that
it would not be just and equitable if contributions pursuant to this Section 10(e) were to be determined by pro rata
allocation or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount
paid or payable by an indemnified party as a result of the loss, claim, liability, expense, or damage, or action in respect thereof, referred
to above in this Section 10(e) shall be deemed to include, for the purpose of this Section 10(e), any legal
or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim
to the extent consistent with Section 10(c) hereof. Notwithstanding the foregoing provisions of this Section 10(e),
the Agent shall not be required to contribute any amount in excess of the commissions received by it under this Agreement and no person
found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled
to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 10(e),
any person who controls a party to this Agreement within the meaning of the Securities Act, any affiliates of the Agent and any officers,
directors, partners, employees or agents of the Agent or any of its affiliates, will have the same rights to contribution as that party,
and each director of the Company and each officer of the Company who signed the Registration Statement will have the same rights to contribution
as the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after receipt of notice of
commencement of any action against such party in respect of which a claim for contribution may be made under this Section 10(e),
will notify any such party or parties from whom contribution may be sought, but the omission to so notify will not relieve that party
or parties from whom contribution may be sought from any other obligation it or they may have under this Section 10(e) except
to the extent that the failure to so notify such other party materially prejudiced the substantive rights or defenses of the party from
whom contribution is sought. Except for a settlement entered into pursuant to the last sentence of Section 10(c) hereof,
no party will be liable for contribution with respect to any action or claim settled without its written consent if such consent is required
pursuant to Section 10(c) hereof.
11. Representations
and Agreements to Survive Delivery. The indemnity and contribution agreements contained in Section 10 of this Agreement
and all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective
dates, regardless of (i) any investigation made by or on behalf of the Agent, any controlling persons, or the Company (or any of
their respective officers, directors, employees or controlling persons), (ii) delivery and acceptance of the Placement Shares and
payment therefor or (iii) any termination of this Agreement.
12. Termination.
(a) The
Agent may terminate this Agreement, by notice to the Company, as hereinafter specified at any time (1) if there has been, since the
time of execution of this Agreement or since the date as of which information is given in the Prospectus, any change, or any development
or event involving a prospective change, in the condition, financial or otherwise, or in the business, properties, earnings, results of
operations or prospects of the Company and its Subsidiaries considered as one enterprise, whether or not arising in the ordinary course
of business, which individually or in the aggregate, in the sole judgment of the Agent is material and adverse and makes it impractical
or inadvisable to market the Placement Shares or to enforce contracts for the sale of the Placement Shares, (2) if there has occurred
any material adverse change in the financial markets in the United States or the international financial markets, any outbreak of hostilities
or escalation thereof or other calamity or crisis or any change or development involving a prospective change in national or international
political, financial or economic conditions, in each case the effect of which is such as to make it, in the judgment of the Agent, impracticable
or inadvisable to market the Placement Shares or to enforce contracts for the sale of the Placement Shares, (3) if trading in the
Common Stock has been suspended or limited by the Commission or the Exchange, or if trading generally on the Exchange has been suspended
or limited, or minimum prices for trading have been fixed on the Exchange, (4) if any suspension of trading of any securities of
the Company on any exchange or in the over-the-counter market shall have occurred and be continuing, (5) if a major disruption of
securities settlements or clearance services in the United States shall have occurred and be continuing, or (6) if a banking moratorium
has been declared by either U.S. Federal or New York authorities. Any such termination shall be without liability of any party to any
other party except that the provisions of Section 8 (Payment of Expenses), Section 10 (Indemnification and Contribution),
Section 11 (Representations and Agreements to Survive Delivery), Section 17 (Governing Law and Time; Waiver of
Jury Trial) and Section 18 (Consent to Jurisdiction) hereof shall remain in full force and effect notwithstanding such termination.
If the Agent elects to terminate this Agreement as provided in this Section 12(a), the Agent shall provide the required notice
as specified in Section 13 (Notices).
(b) The
Company shall have the right, by giving ten (10) days’ notice as hereinafter specified to terminate this Agreement in its sole
discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party
except that the provisions of Section 8, Section 10, Section 11, Section 17 and Section 18
hereof shall remain in full force and effect notwithstanding such termination.
(c) The
Agent shall have the right, by giving ten (10) days’ notice as hereinafter specified to terminate this Agreement in its sole
discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party
except that the provisions of Section 8, Section 10, Section 11, Section 17 and Section 18
hereof shall remain in full force and effect notwithstanding such termination.
(d) This
Agreement shall remain in full force and effect unless terminated pursuant to Sections 12(a), (b), or (c) above
or otherwise by mutual agreement of the parties; provided, however, that any such termination by mutual agreement shall
in all cases be deemed to provide that Section 8, Section 10, Section 11, Section 17 and
Section 18 shall remain in full force and effect.
(e) Any
termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however,
that such termination shall not be effective until the close of business on the date of receipt of such notice by the Agent or the Company,
as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares
shall settle in accordance with the provisions of this Agreement.
13. Notices.
All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement
shall be in writing, unless otherwise specified, and if sent to the Agent, shall be delivered to:
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
| |
Attention: |
Capital Markets |
| |
Email: |
CFCEO@cantor.com |
and:
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
| |
Attention: |
General
Counsel |
| |
Email: |
legal-IBD@cantor.com |
with a copy to:
Duane Morris LLP
1540 Broadway
New York, NY 10036
Attention: James
T. Seery
Telephone: (973)
424-2088
Email: jtseery@duanemorris.com
and if to the Company,
shall be delivered to:
Elutia Inc.
12510 Prosperity Drive, Suite 370
Silver Spring, MD 20904
Attention: Chief
Finance Officer
Email: mferguson@elutia.com
and jhamet@elutia.com
with a copy to:
Kilpatrick Townsend & Stockton
LLP
1100 Peachtree Street NE, Suite 2800
Atlanta, GA 30309
Attention: David
M. Eaton and Michael J. Cochran
Email: deaton@ktslaw.com
and mcochran@ktslaw.com
Each party to this Agreement
may change such address for notices by sending to the parties to this Agreement written notice of a new address for such purpose. Each
such notice or other communication shall be deemed given (i) when delivered personally on or before 4:30 p.m., New York City
time, on a Business Day or, if such day is not a Business Day, on the next succeeding Business Day, (ii) by Electronic Notice, as
set forth below, (iii) on the next Business Day after timely delivery to a nationally-recognized overnight courier and (iv) on
the Business Day actually received if deposited in the U.S. mail (certified or registered mail, return receipt requested, postage prepaid).
For purposes of this Agreement, “Business Day” shall mean any day on which the Exchange and commercial banks
in the City of New York are open for business.
An electronic communication
(“Electronic Notice”) shall be deemed written notice for purposes of this Section 13 if sent to the electronic
mail address specified by the receiving party under separate cover. Electronic Notice shall be deemed received at the time the party sending
Electronic Notice receives verification of receipt by the receiving party. Any party receiving Electronic Notice may request and shall
be entitled to receive the notice on paper, in a nonelectronic form (“Nonelectronic Notice”) which shall be
sent to the requesting party within ten (10) days of receipt of the written request for Nonelectronic Notice.
14. Successors
and Assigns. This Agreement shall inure to the benefit of and be binding upon the Company and the Agent and their respective successors
and the parties referred to in Section 10 hereof. References to any of the parties contained in this Agreement shall be deemed to
include the successors and permitted assigns of such party. Nothing in this Agreement, express or implied, is intended to confer upon
any party other than the parties hereto or their respective successors and permitted assigns any rights, remedies, obligations or liabilities
under or by reason of this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights or obligations
under this Agreement without the prior written consent of the other party; provided, however, that the Agent may assign
its rights and obligations hereunder to an affiliate thereof without obtaining the Company’s consent.
15. Adjustments
for Stock Splits. The parties acknowledge and agree that all share-related numbers contained in this Agreement shall be adjusted to
take into account any stock split, stock dividend or similar event effected with respect to the Placement Shares.
16. Entire
Agreement; Amendment; Severability; Waiver. This Agreement (including all schedules and exhibits attached hereto, side letters and
Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements
and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement nor
any term hereof may be amended except pursuant to a written instrument executed by the Company and the Agent. In the event that any one
or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable
as written by a court of competent jurisdiction, then such provision shall be given full force and effect to the fullest possible extent
that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal
or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder
of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Agreement. No implied waiver
by a party shall arise in the absence of a waiver in writing signed by such party. No failure or delay in exercising any right, power,
or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further
exercise thereof or the exercise of any right, power, or privilege hereunder.
17. GOVERNING
LAW AND TIME; WAIVER OF JURY TRIAL. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF
NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS. SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH PARTY HEREBY
IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING
OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
18. CONSENT
TO JURISDICTION. EACH PARTY HEREBY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING IN THE
CITY OF NEW YORK, BOROUGH OF MANHATTAN, FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH ANY TRANSACTION CONTEMPLATED
HEREBY, AND HEREBY IRREVOCABLY WAIVES, AND AGREES NOT TO ASSERT IN ANY SUIT, ACTION OR PROCEEDING, ANY CLAIM THAT IT IS NOT PERSONALLY
SUBJECT TO THE JURISDICTION OF ANY SUCH COURT, THAT SUCH SUIT, ACTION OR PROCEEDING IS BROUGHT IN AN INCONVENIENT FORUM OR THAT THE VENUE
OF SUCH SUIT, ACTION OR PROCEEDING IS IMPROPER. EACH PARTY HEREBY IRREVOCABLY WAIVES PERSONAL SERVICE OF PROCESS AND CONSENTS TO PROCESS
BEING SERVED IN ANY SUCH SUIT, ACTION OR PROCEEDING BY MAILING A COPY THEREOF (CERTIFIED OR REGISTERED MAIL, RETURN RECEIPT REQUESTED)
TO SUCH PARTY AT THE ADDRESS IN EFFECT FOR NOTICES TO IT UNDER THIS AGREEMENT AND AGREES THAT SUCH SERVICE SHALL CONSTITUTE GOOD AND SUFFICIENT
SERVICE OF PROCESS AND NOTICE THEREOF. NOTHING CONTAINED HEREIN SHALL BE DEEMED TO LIMIT IN ANY WAY ANY RIGHT TO SERVE PROCESS IN ANY
MANNER PERMITTED BY LAW.
19. Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Delivery of an executed Agreement by one party to the other may be made by facsimile, electronic
mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic
Signatures and Records Act or other applicable law, e.g., www.docusign.com) or other transmission method and any counterpart so delivered
shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
20. Construction.
The section and exhibit headings herein are for convenience only and shall not affect the construction hereof. References herein
to any law, statute, ordinance, code, regulation, rule or other requirement of any Governmental Authority shall be deemed to refer
to such law, statute, ordinance, code, regulation, rule or other requirement of any Governmental Authority as amended, reenacted,
supplemented or superseded in whole or in part and in effect from time to time and also to all rules and regulations promulgated
thereunder.
21. Permitted
Free Writing Prospectuses. The Company represents, warrants and agrees that, unless it obtains the prior written consent of the Agent,
and the Agent represents, warrants and agrees that, unless it obtains the prior written consent of the Company, it has not made and will
not make any offer relating to the Placement Shares that would constitute an Issuer Free Writing Prospectus, or that would otherwise constitute
a “free writing prospectus,” as defined in Rule 405, required to be filed with the Commission. Any such free writing
prospectus consented to by the Agent or by the Company, as the case may be, is hereinafter referred to as a “Permitted Free
Writing Prospectus.” The Company represents and warrants that it has treated and agrees that it will treat each Permitted
Free Writing Prospectus as an “issuer free writing prospectus,” as defined in Rule 433, and has complied and will comply
with the requirements of Rule 433 applicable to any Permitted Free Writing Prospectus, including timely filing with the Commission
where required, legending and record keeping. For the purposes of clarity, the parties hereto agree that all free writing prospectuses,
if any, listed in Exhibit 21 hereto are Permitted Free Writing Prospectuses.
22. Absence
of Fiduciary Relationship. The Company acknowledges and agrees that:
(a) the
Agent is acting solely as agent in connection with the public offering of the Placement Shares and in connection with each transaction
contemplated by this Agreement and the process leading to such transactions, and no fiduciary or advisory relationship between the Company
or any of its respective affiliates, stockholders (or other equity holders), creditors or employees or any other party, on the one hand,
and the Agent, on the other hand, has been or will be created in respect of any of the transactions contemplated by this Agreement, irrespective
of whether or not the Agent has advised or is advising the Company on other matters, and the Agent has no obligation to the Company with
respect to the transactions contemplated by this Agreement except the obligations expressly set forth in this Agreement;
(b) it
is capable of evaluating and understanding, and understands and accepts, the terms, risks and conditions of the transactions contemplated
by this Agreement;
(c) neither
the Agent nor its affiliates have provided any legal, accounting, regulatory or tax advice with respect to the transactions contemplated
by this Agreement and it has consulted its own legal, accounting, regulatory and tax advisors to the extent it has deemed appropriate;
(d) it
is aware that the Agent and its affiliates are engaged in a broad range of transactions which may involve interests that differ from those
of the Company and the Agent and its affiliates have no obligation to disclose such interests and transactions to the Company by virtue
of any fiduciary, advisory or agency relationship or otherwise; and
(e) it
waives, to the fullest extent permitted by law, any claims it may have against the Agent or its affiliates for breach of fiduciary duty
or alleged breach of fiduciary duty in connection with the sale of Placement Shares under this Agreement and agrees that the Agent and
its affiliates shall not have any liability (whether direct or indirect, in contract, tort or otherwise) to it in respect of such a fiduciary
duty claim or to any person asserting a fiduciary duty claim on its behalf or in right of it or the Company, employees or creditors of
Company.
23. Definitions.
As used in this Agreement, the following terms have the respective meanings set forth below:
“Applicable Time”
means (i) each Representation Date, (ii) the time of each sale of any Placement Shares pursuant to this Agreement and (iii) each
Settlement Date.
“Governmental
Authority” means (i) any federal, provincial, state, local, municipal, national or international government or governmental
authority, regulatory or administrative agency, governmental commission, department, board, bureau, agency or instrumentality, court,
tribunal, arbitrator or arbitral body (public or private); (ii) any self-regulatory organization; or (iii) any political subdivision
of any of the foregoing.
“Issuer Free Writing
Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433, relating to the Placement
Shares that (1) is required to be filed with the Commission by the Company, (2) is a “road show” that is a “written
communication” within the meaning of Rule 433(d)(8)(i) whether or not required to be filed with the Commission, or (3) is
exempt from filing pursuant to Rule 433(d)(5)(i) because it contains a description of the Placement Shares or of the offering
that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required
to be filed, in the form retained in the Company’s records pursuant to Rule 433(g) under the Securities Act Regulations.
“Rule 164,” “Rule 172,”
“Rule 405,” “Rule 415,” “Rule 424,” “Rule 424(b),”
“Rule 430B,” and “Rule 433” refer to such rules under the Securities
Act Regulations.
All
references in this Agreement to financial statements and schedules and other information that is “contained,” “included”
or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean
and include all such financial statements and schedules and other information that is incorporated by reference in the Registration Statement
or the Prospectus, as the case may be.
All references in this Agreement
to the Registration Statement, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include the copy
filed with the Commission pursuant to EDGAR; all references in this Agreement to any Issuer Free Writing Prospectus (other than any Issuer
Free Writing Prospectuses that, pursuant to Rule 433, are not required to be filed with the Commission) shall be deemed to include
the copy thereof filed with the Commission pursuant to EDGAR; and all references in this Agreement to “supplements” to the
Prospectus shall include, without limitation, any supplements, “wrappers” or similar materials prepared in connection with
any offering, sale or private placement of any Placement Shares by the Agent outside of the United States.
[Signature Page Follows]
If the foregoing correctly
sets forth the understanding between the Company and the Agent, please so indicate in the space provided below for that purpose, whereupon
this letter shall constitute a binding agreement between the Company and the Agent.
| |
Very truly yours, |
| |
|
| |
ELUTIA INC. |
| |
|
| |
By: |
/s/ C. Randal Mills, Ph.D. |
| |
|
Name: C. Randal Mills, Ph.D. |
| |
|
Title: President and Chief Executive Officer |
| | ACCEPTED as of the date first-above written: |
| |
CANTOR FITZGERALD & CO. |
| |
|
| |
By: |
/s/ Sameer Vasudev |
| |
|
Name: Sameer Vasudev |
| |
|
Title: Managing Director |
[Signature Page to Sales Agreement]
SCHEDULE 1
Form of Placement Notice
| | From: | Elutia
Inc. |
| | | |
| To: | Cantor Fitzgerald & Co.
Attention: [·] |
| | | |
| | Subject: | Placement
Notice |
| | | |
| | Date: | [·],
20[·] |
Ladies and Gentlemen:
Pursuant to the terms and
subject to the conditions contained in the Sales Agreement between Elutia Inc., a Delaware corporation (the “Company”),
and Cantor Fitzgerald & Co. (“Agent”), dated March 17, 2025, the Company hereby requests that
the Agent sell up to [·] of the Company’s common stock, par value 0.001 per share, at a minimum market price of $[·] per
share, during the time period beginning [month, day, time] and ending [month, day, time].
SCHEDULE 2
Compensation
The Company shall pay to the
Agent in cash, upon each sale of Placement Shares pursuant to this Agreement, an amount equal to 3.0% of the aggregate gross proceeds
from each sale of Placement Shares.
SCHEDULE 3
Notice Parties
The Company
Matt Ferguson (mferguson@elutia.com)
With copies to:
Jeff Hamet (jhamet@elutia.com)
The Agent
Sameer Vasudev (svasudev@cantor.com)
With copies to:
CFCEO@cantor.com
SCHEDULE 4
Subsidiaries
Incorporated by reference to Exhibit 21.1 of the Company’s
most recently filed Form 10-K, as applicable.
Exhibit 21
Permitted Free Writing Prospectus
None.
EXHIBIT 5.1
 |
Kilpatrick Townsend &
Stockton LLP
ktslaw.com |
Suite 2800, 1100 Peachtree
Street NE
Atlanta, GA 30309-4528 |
March 17, 2025
Elutia Inc.
12510 Prosperity Drive
Suite 370
Silver Spring, MD 20904
Re: Registration
Statement on Form S-3
Ladies and Gentlemen:
We have acted as counsel to
Elutia Inc., a Delaware corporation (“Elutia”), in connection with its preparation and filing of a Registration Statement
on Form S-3 (the “Registration Statement”) with the Securities and Exchange Commission (the “Commission”)
on the date hereof pursuant to the Securities Act of 1933, as amended (the “Securities Act”), relating to the registration
under the Securities Act and the proposed issuance and sale from time to time by Elutia of an indeterminate amount of: (i) one or
more series of Elutia’s debt securities (the “Debt Securities”); (ii) warrants of Elutia (the “Warrants”)
to purchase Common Stock, Preferred Stock or Debt Securities; (iii) shares of Elutia’s Class A common stock, par value
$0.001 per share (the “Class A Common Stock”); (iv) shares of Elutia’s Class B common stock, par
value $0.001 per share (the “Class B Common Stock”, and together with the Class A Common Stock, the “Common
Stock”); (v) shares of one or more series of Elutia’s preferred stock (the “Preferred Stock”);
and (vi) units of Elutia (the “Units”) representing a combination of one or more Securities (as defined below)
other than Units. The Debt Securities, Warrants, Common Stock, Preferred Stock and Units are collectively referred to herein as the “Securities”
and individually as a “Security.” The offering of the Securities will be made as set forth in the prospectus contained
in the Registration Statement (the “Base Prospectus”), as that Base Prospectus is supplemented by one or more prospectus
supplements from time to time (each such prospectus supplement, together with the Base Prospectus, a “Prospectus”).
The Registration Statement
also relates to the issuance and sale of up to $50,000,000 of Class A Common Stock (the “Placement Shares”) pursuant
to the sales agreement prospectus contained in the Registration Statement (the “Sales Agreement Prospectus”). We understand
that the Company has agreed to issue and sell the Placement Shares from time to time through Cantor Fitzgerald & Co., as sales
agent (the “Sales Agent”) pursuant to a Controlled Equity OfferingSM Sales Agreement dated March 17,
2025 by and among the Company and the Sales Agent (the “Sales Agreement”).
In connection with this opinion,
we have examined originals, or copies certified or otherwise identified to our satisfaction, of such records, certificates of corporate
officers and government officials, instruments and other documents, as we have deemed necessary or appropriate for purposes of this opinion.
As to any facts material to the opinions expressed herein, we have relied upon statements and representations of officers and other representatives
of Elutia and others, without independent verification of their accuracy.
Anchorage
Atlanta Augusta BEIJING Charlotte CHICAGO DALLAS Denver houston los angeles New York PHOENIX Raleigh
San
Diego San Francisco Seattle SHANGHAI Silicon Valley Stockholm Tokyo Walnut Creek Washington Winston-Salem
March 17, 2025
Page 2
In our examination, we have
assumed the legal capacity of all natural persons, the genuineness of all signatures, the authenticity of all documents submitted to us
as originals and the conformity to original documents of all documents submitted to us as certified, conformed, facsimile, electronic
or photostatic copies. In making our examination of documents executed or to be executed, we have assumed that the parties thereto had
or will have the power, corporate or other, to enter into and perform all obligations thereunder and have also assumed the due authorization
by all requisite action, corporate or other, and execution and delivery by such parties of such documents and (except with respect to
the Securities, to the extent in our numbered opinions below) the validity and binding effect thereof on such parties.
In rendering our opinions
below, we have also assumed that: (i) the Registration Statement and any supplements and amendments thereto (including any post-effective
amendments) will have become and remain effective, will not be subject to any stop order and will comply with all applicable laws; (ii) a
prospectus supplement will have been prepared and filed with the Commission describing the Securities to be offered for sale thereby in
accordance with all applicable laws; (iii) all Securities will be issued and sold in compliance with all applicable federal and state
securities laws and in the manner stated in the Registration Statement and the applicable prospectus supplement; (iv) none of the
terms of any Security to be established subsequent to the date hereof, nor the issuance and delivery of such Security, nor the compliance
by Elutia with the terms of such Security will violate any applicable law or will result in a violation of any provision of any instrument
or agreement then binding upon Elutia or any restriction imposed by any court or governmental body having jurisdiction over Elutia;
(v) a definitive purchase, underwriting or similar agreement and any other necessary agreement with respect to any Securities offered
(including any applicable trust indenture) will have been duly authorized and validly executed and delivered by Elutia and the other parties
thereto; (vi) any applicable indenture, Debt Security, warrant agreement, Warrant or unit agreement will be governed by the laws
of the State of New York; (vii) any Securities issuable upon conversion, exchange or exercise of any Security being offered
or issued will be duly authorized, created and, if appropriate, reserved for issuance by all necessary corporate action of Elutia; and
(viii) with respect to shares of Common Stock or Preferred Stock, there will be sufficient shares of Common Stock or Preferred Stock,
as applicable, authorized under Elutia’s Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”),
and not otherwise reserved for issuance. Furthermore, and without limiting the foregoing, with respect to the Placement Shares, we have
assumed that (i) each sale of the Placement Shares will be duly authorized by the Board of Directors of the Company, a duly authorized
committee thereof or a person or body pursuant to an authorization granted in accordance with Section 152 of the General Corporation
Law of the State of Delaware (the “DGCL”) and (ii) no more than 25,000,000 Placement Shares will be sold for a
consideration not less than the par value of the Class A Common Stock.
Based upon the foregoing and
subject to the limitations, qualifications and assumptions set forth herein and in reliance on the statements of fact contained in the
documents that we have examined, we are of the opinion that, as of the date hereof:
1. With
respect to the Debt Securities, when (a) an indenture with respect to such Debt Securities (an “Applicable Indenture”)
has been duly authorized, executed and delivered by all necessary corporate action of Elutia, (b) the Applicable Indenture has been
duly qualified under the Trust Indenture Act of 1939, as amended, (c) the specific terms of a particular series of Debt Securities
have been duly established in accordance with the terms of the Applicable Indenture and authorized by all necessary corporate action of
Elutia, and (d) such Debt Securities have been duly executed, authenticated, issued and delivered against payment therefor in accordance
with the terms of the Applicable Indenture and in the manner contemplated by the applicable Prospectus and by such corporate action, such
Debt Securities will be the legally valid and binding obligations of Elutia, enforceable against Elutia in accordance with their terms.
2. With
respect to Warrants, when (a) any applicable warrant agreement has been duly authorized, executed and delivered by all necessary
corporate action of Elutia, (b) the specific terms of a particular issuance of Warrants have been duly established in accordance
with the terms of any applicable warrant agreement and authorized by all necessary corporate action of Elutia, and (c) such Warrants
have been duly executed, authenticated, issued and delivered against payment therefor in accordance with the terms of any applicable warrant
agreement and in the manner contemplated by the applicable Prospectus and by such corporate action, such Warrants will be the legally
valid and binding obligations of Elutia, enforceable against Elutia in accordance with their terms.
March 17, 2025
Page 3
3. With
respect to Common Stock, when an issuance of Common Stock has been duly authorized by all necessary corporate action of Elutia, upon
issuance, delivery and payment therefor in an amount not less than the par value thereof in the manner contemplated by the applicable
Prospectus and by such corporate action, and in total amounts and numbers of shares that do not exceed (a) the respective total
amounts and numbers of shares available under the Articles of Incorporation and (b) the total amounts and number of shares authorized
by the board of directors of Elutia in connection with the offering contemplated by the applicable Prospectus, such shares of Common
Stock will be validly issued, fully paid and nonassessable. In rendering the foregoing opinion, we have assumed that Elutia will comply
with all applicable notice requirements regarding uncertificated shares provided in the DGCL.
4. With
respect to Preferred Stock, when a series of Preferred Stock has been duly established in accordance with the terms of the Articles of
Incorporation (including the adoption and filing with the Secretary of State of the State of Delaware of a Certificate of Designation
relating to such Preferred Stock), and authorized by all necessary corporate action of Elutia, upon issuance, delivery and payment therefor
in an amount not less than the par value thereof in the manner contemplated by the applicable Prospectus and by such corporate action,
and in total amounts and numbers of shares that do not exceed (a) the respective total amounts and numbers of shares available under
the Articles of Incorporation, and (b) the total amounts and numbers of shares authorized by the board of directors of Elutia in
connection with the offering contemplated by the applicable Prospectus, such shares of such series of Preferred Stock will be validly
issued, fully paid and nonassessable. In rendering the foregoing opinion, we have assumed that Elutia will comply with all applicable
notice requirements regarding uncertificated shares provided in the DGCL.
5. With
respect to Units, when (a) the applicable unit agreement has been duly authorized, executed and delivered by all necessary corporate
action of Elutia, (b) the specific terms of a particular issuance of Units have been duly authorized in accordance with the terms
of the applicable unit agreement and authorized by all necessary corporate action of Elutia, and (c) such Units have been duly executed,
authenticated, issued and delivered against payment therefor in accordance with the terms of the applicable unit agreement and in the
manner contemplated by the applicable Prospectus and by such corporate action, such Units will be the legally valid and binding obligations
of Elutia, enforceable against Elutia in accordance with their terms.
6. The
Placement Shares, when sold and issued against payment therefor in accordance with the Sales Agreement, the Registration Statement and
the Sales Agreement Prospectus, will be validly issued, fully paid and nonassessable.
Our opinions set forth above
are subject to (i) applicable bankruptcy, insolvency, reorganization, fraudulent conveyance and transfer, moratorium or other laws
now or hereafter in effect relating to or affecting the rights or remedies of creditors generally and (ii) general principles of
equity (whether applied in a proceeding at law or in equity) including, without limitation, standards of materiality, good faith, fair
dealing and reasonableness in the interpretation and enforcement of contracts and the discretion of the court before which any proceeding
may be brought, and the application of such principles to limit the availability of equitable remedies such as specific performance.
March 17, 2025
Page 4
We express no opinion regarding:
(i) any waiver of stay, extension or usury laws or of unknown future rights; (ii) any waiver (whether or not stated as such)
under the Applicable Indenture, the Debt Securities, any applicable warrant agreements, the Warrants, any applicable unit agreements or
the Units or the Sales Agreement (collectively, the “Documents”) of, or any consent thereunder relating to, unknown
future rights or the rights of any party thereto existing, or duties owing to it, as a matter of law; (iii) any waiver (whether or
not stated as such) contained in any Document of rights of any party, or duties owing to it, that is broadly or vaguely stated or does
not describe the right or duty purportedly waived with reasonable specificity; (iv) provisions relating to indemnification, exculpation
or contribution, to the extent such provisions may be held unenforceable as contrary to public policy or federal or state securities laws
or due to the negligence or willful misconduct of the indemnified party; (v) any provision under any Document waiving the right to
object to venue in any court; (vi) any waiver of the right to jury trial; (vii) any agreement to submit to the jurisdiction
of any Federal court; (viii) any provision providing for the payment of any judgment or decree in currency other than U.S. dollars;
(ix) any provision for liquidated damages, default interest, late charges, monetary penalties, make-whole premiums or other economic
remedies to the extent such provisions are deemed to constitute a penalty; (x) any provision requiring the payment of attorneys’
fees, where such payment is contrary to law or public policy; (xi) any provision permitting, upon acceleration of any Debt Securities,
collection of that portion of the stated principal amount thereof which might be determined to constitute unearned interest thereon; (xii) the
creation, validity, attachment, perfection, or priority of any lien or security interest; (xiii) setoff rights; (xiv) proxies,
powers and trusts, (xv) provisions prohibiting, restricting, or requiring consent to assignment or transfer of any right or property;
(xvi) any provision to the effect that every right or remedy is cumulative and may be exercised in addition to any other right or
remedy or that the election of some particular remedy does not preclude recourse to one or more others; or (xvii) the severability
of provisions to the foregoing effect.
We are opining herein only
as to DGCL and the laws of the State of New York.
This opinion has been prepared
for your use in connection with the Registration Statement. We assume no obligation to advise you of any change in the foregoing subsequent
to the effectiveness of the Registration Statement even though the change may affect the legal analysis or a legal conclusion or other
matters in this opinion letter. This opinion may not be furnished to or relied upon by any person or entity for any purpose without our
prior written consent.
March 17, 2025
Page 5
This opinion letter speaks
only as of its date and is delivered in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Securities
Act. We consent to your filing this opinion as an exhibit to the Registration Statement and to the reference to our firm contained under
the heading “Legal Matters” in the Base Prospectus. In giving this consent, we do not hereby admit that we come within the
category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations thereunder.
| | Sincerely, |
| | | |
| | | /s/ KILPATRICK TOWNSEND &
STOCKTON LLP |
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
We hereby consent to the incorporation by reference
in this Registration Statement on Form S-3 of Elutia Inc. of our report dated March 11, 2025 relating to the financial
statements, which appears in Elutia Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024. We also consent
to the reference to us under the heading “Experts” in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
Philadelphia, Pennsylvania
March 17, 2025
Exhibit 107
Calculation of Filing Fee Tables
Form S-3
(Form Type)
ELUTIA INC.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered and Carry Forward
Securities
| |
Security
Type |
Security
Class
Title |
Fee
Calculation
or Carry
Forward
Rule |
Amount
Registered |
Proposed
Maximum
Offering
Price Per
Unit |
Maximum
Aggregate
Offering Price |
Fee
Rate |
Amount
of
Registration
Fee(3) |
Carry
Forward
Form
Type |
Carry
Forward
File
Number |
Carry
Forward
Initial
effective
date |
Filing Fee
Previously
Paid In
Connection
with
Unsold
Securities
to be
Carried
Forward |
| Newly
Registered Securities |
| Fees
to Be Paid |
Equity |
Class A
Common Stock, par value $0.001 per share |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Equity |
Class B
Common Stock, par value $0.001 per share |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Equity |
Preferred
Stock |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Other |
Warrants |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Debt |
Debt
Securities |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Other |
Units |
457(o) |
(1) |
(2) |
(2) |
- |
- |
- |
- |
- |
- |
| |
Unallocated
(Universal) Shelf |
Unallocated
(Universal) Shelf |
457(o) |
(1) |
(2) |
$100,000,000(3) |
0.0001531 |
$15,310 |
- |
- |
- |
- |
| Fees
Previously Paid |
N/A |
N/A |
N/A |
N/A |
N/A |
N/A |
N/A |
N/A |
- |
- |
- |
- |
| Carry
Forward Securities |
| Carry
Forward Securities |
N/A |
N/A |
N/A |
N/A |
|
N/A |
|
|
N/A |
N/A |
N/A |
N/A |
| |
Total
Offering Amounts |
|
|
|
$100,000,000 |
|
|
|
|
| |
Total
Fee Previously Paid |
|
|
|
N/A |
|
|
|
|
| |
Total
Fee Offsets |
|
|
|
$1,018 |
|
|
|
|
| |
Net
Fee Due |
|
|
|
$14,292 |
|
|
|
|
Table 2: Fee Offset Claims and Sources
| |
Registrant
or
Filer Name |
Form or
Filing Type |
File
Number |
Initial
Filing
Date |
Filing
Date |
Fee
Offset
Claimed |
Security
Type
Associated
with Fee
Offset
Claimed |
Security
Title
Associated
with Fee
Offset
Claimed |
Unsold
Securities
Associated
with Fee
Offset
Claimed |
Unsold
Aggregate
Offering
Amount
Associated
with Fee
Offset
Claimed |
Fee
Paid with
Fee Offset
Source |
| Rule 457(p) |
| Fee Offset Claims |
Elutia Inc. |
Form S-3 |
333-267197 |
August 31, 2022 |
- |
$1,018 |
Unallocated (Universal Shelf)(4) |
Unallocated (Universal Shelf)(4) |
Unallocated (Universal Shelf)(4) |
$10,978,705 |
- |
| Fee Offset Sources |
Elutia Inc. |
Form S-3 |
333-267197 |
- |
August 31, 2022 |
- |
- |
- |
- |
- |
$1,018 |
| (1) | There are being registered under this registration statement such indeterminate number of common stock
shares, preferred stock shares, debt securities, warrants and units, as may be sold by the registrant from time to time, which collectively
shall have an aggregate initial offering price not to exceed $100,000,000. The securities registered hereunder also include such indeterminate
number of shares of common stock as may be issued upon conversion, exercise or exchange of debt securities or warrants that provide for
such conversion into, exercise for or exchange into common stock. In addition, pursuant to Rule 416 under the Securities Act of 1933,
as amended (the “Securities Act”), the common stock being registered hereunder include such indeterminate number of shares
of common stock as may be issuable with respect to the common stock being registered hereunder as a result of stock splits, stock dividends,
or similar transactions. If any debt securities are issued at an original issue discount, then the offering may be in such greater principal
amount as shall result in a maximum aggregate offering price not to exceed $100,000,000 after the date hereof. Includes rights to acquire
Class A common stock, Class B common stock or preferred stock of the Company under any shareholder rights plan then in effect,
if applicable under the terms of any such plan. |
| (2) | The proposed maximum aggregate offering price per class of security will be determined from time to time
by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to
each class of security pursuant to Item 16(b) of Form S-3 under the Securities Act. |
| (3) | Estimated solely for purposes of determining the registration fee pursuant to Rule 457(o) under
the Securities Act of 1933. |
| (4) | Pursuant to Rule 457(p) under the Securities Act, the registrant is offsetting $1,018 of the
fee associated with this registration statement from the fee previously paid by the registrant associated with the unsold securities registered
under the registrant’s prior unallocated (universal) shelf registration statement on Form S-3 of its common stock, preferred
stock, warrants, debt securities and units filed on August 31, 2022 (File No. 333-267197) (the “Prior Registration Statement”).
The registrant registered $50,000,000 of securities under the Prior Registration Statement, paid a fee of $4,635 in connection with it
and issued approximately $39,021,295 of securities thereunder. The registrant has terminated or completed any offering that included the
unsold securities associated with the claimed offset under the Prior Registration Statement, and such unsold securities are immediately
deemed deregistered upon the filing of this registration statement. |
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